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Defibrillators Type Comparison: External, Automated, Semi Automated
Defibrillators Type Comparison: External, Automated, Semi Automated
Product Comparison
Defibrillators, External, Automated; Semiautomated
UMDNS information
This Product Comparison covers the following device terms and product codes as listed in ECRI’s Universal Medical Device
Nomenclature System™ (UMDNS™):
9 Defibrillators, External, Automated [17-116]
9 Defibrillators, External, Semiautomated [18-500]
Table of Contents
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July 2005
Defibrillators, External, Automated; Semiautomated
Purpose
AEDs deliver a high-amplitude current impulse to the heart in order to restore normal rhythm
and contractile function in patients who are experiencing ventricular fibrillation (VF) or ventricular
tachycardia (VT) that is not accompanied by a
palpable pulse. AEDs differ from conventional
defibrillators in that AEDs can analyze the ECG
rhythm to determine whether defibrillation is
necessary; this eliminates the need for the user to
interpret the cardiac rhythm before delivering a
shock. AEDs are designed to be used primarily by
first responders to cardiac emergencies, who may
not be fully trained in advanced cardiac life support
(ACLS). In the prehospital setting, these emergency
personnel can include emergency medical
technicians (EMTs), firefighters, law enforcement
officers, and paramedics. More recently, flight
attendants, security guards, and others (sometimes
called traditional targeted responders; see Table) may be expected to use PAD units. AEDs can also
be used in areas of the hospital where advanced life support personnel are not readily available.
Cardiac physiology
The heart is stimulated to contract by a group of specialized myocardial cells called the sinoatrial
(SA) node, located at the junction of the superior vena cava and the right atrium. The SA node is the
heart’s natural pacemaker; it generates a spontaneous electrical stimulus that is conducted through
the atria and causes them to contract. The electrical stimulus is transmitted to the atrioventricular
(AV) node, located at the septal wall of the right atrium, and eventually to the ventricles,
Prehospital
Prehospital users can be classified as follows:
• First responders — Trained individuals who have a duty to respond to medical
emergencies. Examples include emergency medical services (EMS) personnel,
police officers, and firefighters.
• Targeted responders — Individuals within the general public who are likely or
willing to act in the case of a medical emergency, trained in AED use, and given
access to an AED. Targeted responders can be further classified as traditional or
nontraditional targeted reponders.
• Traditional targeted responders are individuals who, although they are not
first responders, are likely to perceive a duty to respond to a medical
emergency. Examples include security guards, stadium and golf course
personnel, and flight attendants.
• Nontraditional targeted responders are individuals within the general
public who express a willingness to respond to medical emergencies and
who volunteer for training. Examples include residents of large apartment
buildings, workers in high-rise office buildings, and even family members of
individuals known to be at risk for sudden cardiac arrest.
• Other members of the lay public — Some observers speculate that AEDs may, in
the future, be used by members of the public who have not specifically been
trained in AED use and who have not formally been given access to an AED. A
passerby who might otherwise perform cardiopulmonary resuscitation would be
one example of this type of user. (Note that AEDs are not currently marketed for
this purpose.)
In-hospital
AEDs are used in the hospital to help reduce cardiac arrest response times in certain
areas of the facility and even to replace the more expensive manual defibrillator/monitors for
some applications. Within the hospital, the device may be used in one of two different
implementation schemes, depending on the location of use and the staff’s level of training.
In-hospital users can be classified as follows:
• Advanced as well as basic users — The same device is used as an automated
unit by first-responding nurses or other personnel trained in basic life support
(BLS) and, if necessary, as a manual unit by physicians, members of the
resuscitation team, or other staff trained in advanced life support, when they
arrive.
• Basic users only — The device is used strictly as an automated unit by first-
responding nurses or other personnel trained in BLS. From an AED training
and use standpoint, this scheme is similar to prehospital use of an AED by first
responders.
then resume normal function, and sinus rhythm can be restored. The earlier defibrillation occurs
after the onset of VF, the better the chance for survival; for every minute that passes after the onset
of VF, the chance for survival decreases by 10%. Performing cardiopulmonary resuscitation (CPR)
while waiting for a defibrillator can extend VF and delay the onset of asystole; however, CPR cannot
convert VF to a normal sinus rhythm. Because AEDs are simpler to operate and can be used by
personnel with considerably less training than those qualified to perform ACLS, they permit first
responders to defibrillate, which can reduce the patient’s time in fibrillation and improve the
patient’s prognosis.
Principles of operation
AEDs can be classified as either fully automatic or semiautomatic. Fully automatic models
require only that the user apply defibrillator electrodes to the patient and activate the unit, which
then analyzes the ECG rhythm obtained through the disposable defibrillation electrodes and
determines whether a defibrillation countershock is needed; if it is, the device automatically charges
and discharges.
Most AEDs are semiautomatic. These units analyze the patient’s ECG and notify the operator
when defibrillation is indicated and charge automatically. The operator then discharges the
defibrillator. AEDs can use visual messages and/or voice-synthesized instructions to notify the
operator of the proper course of action.
AEDs typically include a code documentation device, such as a
cassette recorder, memory module, or personal computer data
card; disposable adhesive defibrillation electrodes through which
the cardiac rhythm can be monitored and the electric shock
delivered; an LCD (liquid crystal display) or other display to give
the user status messages (patient and/or defibrillator), to display
the ECG waveform, or to prompt the user to initiate a shock; and
audible voice prompts.
Defibrillator waveform
Defibrillation procedure
Operators are trained to use an AED only on patients in cardiac arrest who are unconscious,
pulseless, and not breathing spontaneously. To avoid misinterpretation from analysis of a rhythm
that is not associated with cardiac arrest, an accurate assessment of the presence of cardiac arrest is
very important before connecting the patient to an AED. Once cardiac arrest is confirmed, the AED
is turned on, and, if available, a voice recorder is automatically activated to document the user’s
comments and other sounds at the emergency scene. The patient’s ECG can also be recorded. The
operator attaches two adhesive defibrillator electrodes to the cables or directly to the AED and
applies the electrodes to the patient. One electrode is usually placed on the patient’s chest near the
upper-right sternal border, and the other is placed on the lower-left ribs over the apex of the heart.
The adhesive electrodes must be carefully applied to ensure good contact with the skin because
unlike paddles, these electrodes do not allow the user to apply pressure and thereby lower
transthoracic impedance by reducing the resistance between the patient’s skin and the electrodes.
All biphasic AEDs measure chest impedance during the first 1/1,000 of a second of the shock. The
shock can then be altered to deliver the appropriate output for the particular patient.
After the electrodes have been attached to the patient, CPR is discontinued, and either the user
activates the analysis function or the AED will automatically analyze the rhythm to determine
whether defibrillation is necessary. After analysis is initiated, all physical contact with the patient
must cease for the remainder of the defibrillation process. Depending on the AED, analysis takes
from 5 to 15 seconds; in fully automatic models, a shock is then automatically delivered when the
rhythm analysis determines it is necessary. Before the shock, the AED indicates that the capacitors
are charging and warns that a shock is imminent. In semiautomatic units, LCDs, visual alarms, or
voice-synthesized instructions prompt the user to press a button to deliver the shock. Before a shock
is delivered, the user of any defibrillator must alert the immediate personnel to the impending shock
by loudly stating “clear” or a similar warning.
After the first shock, analysis is activated again either manually or automatically, and the
defibrillator reanalyzes the cardiac rhythms to determine whether the heart has resumed its normal
beat. If fibrillation is still occurring, the device alerts the user and advises another shock. This
procedure repeats until three shocks have been delivered to the patient. CPR should be resumed for
one minute if normal rhythm has not been restored after the third shock; if the patient is confirmed
to be pulseless and not breathing after CPR, the defibrillation procedure should be resumed.
AEDs use algorithms to analyze a patient’s cardiac rhythm. A number of ECG signal
characteristics are analyzed, including amplitude, frequency, and waveform shape. Analysis
typically begins by dividing the ECG into discrete segments, each a few seconds long. Most AEDs
require that at least two of three consecutive segments analyzed elicit a decision to shock before a
shock can be delivered. Most AEDs attempt to filter out sources of interference capable of generating
artifacts on a patient’s ECG that might lead to misinterpretation. Most AEDs can also check for poor
electrode contact or loose or damaged electrodes; some units are designed to detect a patient’s
movements and/or the moving of a patient by others.
Pediatric application
Some AED suppliers have received U.S. Food and Drug Administration (FDA) approval to use
their devices on children younger than eight years of age. When pediatric pads are attached to an
AED, the delivered energy should be limited to levels safe for pediatric patients. Alternatively, if the
unit is not intended for use with pediatric patients, either (1) pediatric pads should not be able to be
connected, or (2) if they can be connected, the unit should not deliver a shock. For more information
on pediatric defibrillation, see the Health Devices citation below.
Accuracy
be shocked (e.g., VF). It is defined as the percent of correct decisions to shock out of the total number
of truly shockable rhythms. Specificity represents the ability of an AED to identify rhythms that
should not be shocked. It is defined as the percent of truly nonshockable rhythms that the device
made the correct decision not to shock. Ideally, AEDs would have 100% sensitivity as well as 100%
specificity. However, this is not realistic because there are trade-offs between the two. In general,
AEDs favor specificity: they avoid shocking nonshockable rhythms. In addition, the recommended
practice of attaching AEDs only to pulseless, unconscious patients helps to ensure that they will not
be used to analyze a large number of nonshockable rhythms.
The American National Standards Institute/Association for the Advancement of Medical
Instrumentation (ANSI/AAMI) standard for AEDs and remote-control defibrillators provides
minimum performance standards by which to measure the results of AED testing (see Standards
and Guidelines below). According to this standard, the sensitivity for recognizing VF at an amplitude
of 200 µV or greater should exceed 90% in the absence of artifact. For devices that detect VT, the
sensitivity should exceed 75%. The specificity of the device in correctly differentiating nonshockable
rhythms should exceed 95% in the absence of artifact.
AEDs use sealed lead-acid (SLA), nickel-cadmium, or lithium batteries. When possible, SLA
batteries not being used should be charged continuously at room temperature until they are fully
charged, which can take from 4 to 24 hours. Units that offer disposable lithium batteries do not
require recharging, thus simplifying AED use. Most AED manufacturers recommend that batteries
be charged after each use and replaced every one to two years. Although battery life depends heavily
on usage and maintenance practices, routine replacement better ensures that the battery will
provide the desired performance when needed. Rechargeable batteries should not be used in PAD
applications. For a more detailed discussion, see the Health Devices article on battery maintenance
listed below.
One unit covered in this Product Comparison is designed for in-hospital monitoring and automatic
defibrillation of patients who are deemed to be at high risk of sudden cardiac arrest. The unit
continuously monitors the patient’s cardiac rhythms through disposable electrodes and responds by
automatically delivering either cardioversion pacing or shock within seconds of detecting VT or VF,
depending on the rhythm detected. After setting up the device and attaching the electrodes to the
patient, no clinical personnel are needed to deliver the therapy.
Over-the-counter AED
For the first time, the U.S. FDA has cleared an AED for over-the-counter sale. The device is
designed for lay users to use on patients at least 8 years old and weighing at least 55 pounds;
smaller pads for use on infants are available by prescription. FDA notes that the device is covered as
a tracked device used outside user facilities under the Safe Medical Devices Act. Healthcare facilities
supplying AEDs for use outside the facility (e.g., physician offices, off-site imaging centers, patient
homes) should have tracking provisions in place to notify the manufacturer at receipt, upon request,
and on permanent disposal of the devices as they would for other tracked devices. FDA’s
announcement is available at http://www.fda.gov/bbs/topics/ANSWERS/2004/ANS01314.html.
Reported problems
One problem associated with defibrillation is skin burns at the electrode sites. First- and second-
degree burns are especially likely to occur during repeated defibrillation attempts, which require
successively higher energies. Burns are usually caused by a high current flow through a small area
(e.g., an upturned edge of a defibrillation electrode) and/or an increased resistance (e.g., dried gel or
adhesive). In addition to increasing the risk of burns, poor application technique may also reduce the
energy delivered to the patient’s heart.
The operator should avoid physical contact with the patient during defibrillation. Therefore, CPR
and/or mouth-to-mouth resuscitation must be interrupted while the AED performs rhythm analysis,
charges its capacitor, and delivers the electric shock. According to the American Heart Association
(AHA), the incidence of inappropriate shocks with AEDs has been minimal; however, it is
recommended that AEDs be placed in the analysis mode only after all movement — particularly
patient transport — and CPR have stopped.
The U.K. Medicines and Healthcare Products Regulatory Agency (MHRA) has issued a Medical
Device Alert warning healthcare workers of the potential for a higher-than-necessary energy level to
be used with biphasic defibrillators. MHRA states that the rapid advances in biphasic technology
and the differences in energy-level protocols between biphasic and more traditional monophasic
devices have caused confusion in healthcare facilities. In the statement, the organization warns that
the 200 J/200 J/360 J sequence of shocks recommended for monophasic devices is not appropriate for
biphasic devices and that confusion has occurred when both monophasic and biphasic devices are
available in the same clinical area. MHRA recommends that all healthcare providers who might use
a defibrillator be educated and trained regarding appropriate use of the equipment. In particular,
providers should be informed that energy levels may vary among different defibrillators.
The LCD of some AEDs can be harder to see than other display technologies (e.g., CRTs [cathode
ray tubes]), especially if not viewed while standing directly in front of the screen or if viewed in
brightly lit areas, which can cause reflections or dark areas.
Purchase considerations
ECRI recommendations
Included in the accompanying comparison chart are ECRI’s recommendations for minimum
performance requirements for automated and semiautomated defibrillators. The requirements have
been separated into those for standard AEDs (automated and/or semiautomated) and those for PADs
(automated). The two listings are differentiated by the intended user group and application but are
interchangeable in many cases. Both types of unit are designed for users with minimal training.
Standard AEDs will often be placed in areas within the hospital where starting defibrillation
would otherwise take longer than three minutes and will be used by first-responding nurses or
carried by police officers and firefighters who respond to medical emergencies. PAD units are
designed for use by individuals who may arrive on the scene before first responders, such as security
guards and flight attendants. These users often have no medical training but are trained in AED
use. The two types of AEDs will differ mostly by the level of voice prompting, with PADs offering
more detailed instructions.
The ECG must be obtained through disposable defibrillation electrodes. The analysis program
must analyze ECG data and make a decision in less than 14 seconds. The AED must deliver
defibrillation energy at preset levels and sequences. The energy sequences must be programmable
without assistance from service personnel. The AED should charge to maximum energy in less than
15 seconds.
The AED should start analysis automatically or prompt the operator to press an analyze button
when the unit is turned on to prevent delays in initiating analysis. When the AED is not in analyze
mode, the device should provide an audible and visual indication of the presence of, or a change to, a
potentially shockable rhythm. An AED should be able to deliver a set of 3 shocks within 90 seconds;
the AED should not automatically deliver more than 3 successive detection-shock episodes.
ECRI recommends that charge/discharge sequences follow AHA protocols. Semiautomated
defibrillators, which are equipped with a discharge control, should (1) automatically disarm when
fully charged if not intentionally discharged within 10 to 30 seconds after charging, (2) provide a
quick and obvious method of disarming the unit manually if the charge is held for more than 30
seconds, and (3) lose no more than 15% of the initial deliverable energy before automatic disarm in
either AED or manual mode. Fully automated defibrillators should not hold their charge for longer
than 10 seconds before disarming.
Most AEDs on the market employ a biphasic waveform. Because of strong clinical evidence
supporting the superiority of the biphasic waveform technology, ECRI recommends purchasing
biphasic rather than monophasic units.
Manual override can allow a more advanced user to continue a resuscitation attempt upon arrival
without requiring removal of the current defibrillator. This feature would be more commonly found
on standard AEDs.
Other considerations
Due to their simple design and ease of use, AEDs require less user training in rhythm recognition
and device operation, as well as less continuing education time, compared with conventional
defibrillators. However, in applications for which the incidence of cardiac arrest is low, skills
maintenance is important for both conventional defibrillator and AED users.
Some AEDs are equipped with an ECG display. AEDs with ECG displays are useful in
applications in which a person is present who is trained in ACLS and can recognize rhythms by
viewing an ECG. An ECG display will also permit the rescue to continue without the need to detach
the paddles or electrodes to switch the plug-in cord from the AED to a compatible
defibrillator/monitor. On the other hand, an ECG monitor will add to the complexity, size, and cost of
the device. Also, users of AEDs are typically not trained to read ECGs and might be distracted by the
display.
AEDs have various documentation features. Some have dual-channel ECG/voice recorders. Others
have solid-state memory, with a device that stores information summarizing the resuscitation
attempt. Still others have removable data cards or memory modules that can store information for
later review and allow it to be downloaded to a database for storage, trending, and report generation.
AED manufacturers offer various forms of software to facilitate information storage and trending,
but many larger emergency medical services systems have developed their own databases.
Most AEDs use disposable defibrillation electrodes, which typically cost between $13.50 and $36
per pair. Disposable electrodes can be a significant expense, depending on how often the AED is
used. Nonrechargeable batteries typically have a higher list price than rechargeable ones, although
they do not require the purchase of a battery charger. Nonrechargeable batteries can deliver
approximately 200 to 300 discharges and have a shelf life of approximately five years. (Shelf-life
estimates are based on batteries that are not in use. Battery life will decrease when the battery is
installed and if the unit performs periodic self-tests). A nonrechargeable battery can be exhausted
after a few days of training.
Rechargeable batteries allow more discharges over their lifetime. However, the number of
discharges depends on how often the AED is used. A fully charged battery delivers approximately 50
discharges; the battery should be replaced every two years. Cost comparisons cannot be provided
unless the use frequency can be specified. However, as a general rule, nonrechargeable batteries will
be less expensive if the AED is used infrequently, and rechargeable batteries will be less expensive if
device use is average to high. Disposal of nonrechargeable batteries is legal in the United States but
not in some parts of Europe. Users should check their regional regulations. Rechargeable batteries
are usually recycled.
AEDs designed for use by first responders in the prehospital environment should be lightweight
and portable to allow for easy transport. To reduce complexity, many of the advanced features of
manual defibrillator/monitors have been stripped from AEDs. The result is an easy-to-use device
that still has all the capabilities needed for the initial response to cardiac arrest. However, a device
capable of more advanced applications (i.e., a full-featured manual unit) may be required after an
AED is used for the initial rescue.
Savings on AEDs can be realized with a trade-in discount, upgrade, or multiple-purchase
agreement with the supplier. If a facility currently uses older models and newer models are now
necessary, the supplier may provide a considerable trade-in discount (e.g., 20% of the purchase
price). (Suppliers may choose to only allow users to trade in/upgrade devices specific to their product
lines.) If the user is implementing all new models, with no trade-ins or upgrades, a multiple-
purchase discount may be available. This would also apply to all accessories required to operate the
unit or to replace used parts of the defibrillator (e.g., electrode pads).
Stage of development
Defibrillators have been in use for decades, and defibrillation is a well-established and accepted
technique that has undergone extensive clinical testing. AEDs were developed in the late 1970s and
have progressively become smaller, lighter, and more reliable. Originally, AEDs were intended for
use by relatives of people at high risk of VF. However, the initial clinical studies showed less-than-
desirable results in this setting because family members were unable to initiate treatment. Simpler
device operation and better training may again make this a growing area of use. Individuals
qualified to use AEDs include EMTs, firefighters, physicians, nurses, paramedics, other emergency
personnel, and, more recently, security guards and flight attendants. AHA suggests that because
AEDs require less training time and skills maintenance and offer superior device consistency, safety,
and speed of shock delivery, they may completely replace conventional defibrillators at the
prehospital level. Today, these defibrillators have more specific instructions added to voice prompts,
as well as voice prompts for guidance on CPR.
Because two of every three cases of sudden cardiac arrest occur outside the hospital, AEDs have
gained the most widespread acceptance in the prehospital environment, where they are increasingly
being used by EMTs and other first responders. AHA has strongly endorsed the principle of early
defibrillation, which states that “all those whose jobs require that they perform CPR be trained to
operate and permitted to use defibrillators, particularly AEDs.”
AHA’s principle of early defibrillation also encourages the use of AEDs in the hospital. AEDs are
likely to be increasingly important in locations where response times average more than two minutes
(e.g., outpatient and diagnostic areas). However, in many hospitals, defibrillation is still performed
by personnel trained in ACLS, who are often specifically designated to respond to cardiac arrest (e.g.,
code teams), and conventional defibrillator/monitors are still in widespread use.
AHA has suggested extending the principle of early defibrillation to the public, who are often the
first on the scene in cases of cardiac arrest. AEDs are beginning to be placed in locations such as
office buildings, stadiums, fitness clubs, and casinos, where they can be used within minutes of
cardiac arrest. In early 1996, the Cardiac Arrest Survival Act (H.R. 3022) was introduced in
Congress. This legislation calls for a federal program establishing training programs in lifesaving
first aid and the use of AEDs.
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A5496 FDA has designated this Class II Recall No. Z-0356-04 for certain Access CardioSystems
AEDs. The above defibrillators may fail to operate because of a faulty component on the circuit
board. The firm states that the possibility of component failure is very low and depends on use
conditions and notes that no incidents of this failure have been reported with the above units. The
manufacturer initiated a recall by telephone call and e-mail on December 18 and 19, 2003, and by
letter dated December 19, 2003. Verify that you have been contacted by Access CardioSystems.
Identify and remove from service any affected product in your inventory. Source: FDA Enforcement
Rep 2004 Jan 28; Manufacturer.
A5643 (In reference to Action Item Accession No. A4237 dated September 8, 2000 and Action Item
Accession No. A4245 dated September 29, 2000.) FDA has designated this Class II Recall No. Z-
0886-04 for Medtronic LIFEPAK 500 AEDs.The Action Items warned that a limited number of
LIFEPAK 500 defibrillator batteries have an increased risk of battery-cell rupture, which can lead to
staff or patient harm and require repair of the defibrillator before patient use. Medtronic previously
recalled LIFEPAK 500 defibrillator batteries manufactured between September 1998 and April 1999
that had part numbers 3005380-000 through 3005380-006 with battery date codes 9837 through
9920 or part number 3005380-014 with battery date codes 9812 and 9901 through 9905. The
manufacturer has incorporated electrical protection features into the battery design to prevent
similar problems in batteries produced from and after April 2000 and states that this design
modification has proven to be very effective, with no further rupture incidents reported. However,
the firm has received 7 reports of battery-cell rupture involving defibrillator batteries produced
before April 2000 that were not originally recalled. The firm has expanded the recall to include
products with battery date codes below 0013. The manufacturer initiated this recall by letter,
telephone call, and follow-up letter beginning April 2, 2004. Verify that you have received the April
2004 letter or telephone call and follow-up letter from Medtronic. Identify affected product by
removing the battery from the LIFEPAK 500 defibrillator and examining the part number and
battery date code according to the instructions and illustrations included in the letters. If the
battery’s numbers and codes are not in the affected range, the battery may be reinstalled. If the
battery’s numbers and codes are in the affected range, contact Medtronic by telephone to receive a
replacement defibrillator battery. Medtronic will immediately ship the replacement free of charge.
The firm recommends that you leave the affected battery in the defibrillator until the replacement
arrives. After the replacement is installed, turn on the defibrillator to alert the device that a new
battery has been installed. Wait 10 seconds to confirm that the message “Connect Electrodes”
appears. (If any other message appears, contact Medtronic by telephone at the above number for
service.) Turn off the defibrillator. The unit is now ready for use. Return the removed affected
battery to Medtronic using the replacement-battery packaging. Source: FDA Enforcement Rep 2004
May 5; letters submitted by manufacturer.
A5693 FDA has designated this Class II Recall No. Z-0918-04 for certain Welch Allyn AEDs. A faulty
component has been identified in the above defibrillators that could result in an intermittent shock-
button (button number 3) failure. The manufacturer initiated a recall by letter dated April 26, 2004.
The firm would not provide ECRI with any information. Verify that you have received the April 26,
2004 letter from Welch Allyn. Identify and isolate any affected product in your inventory. Source:
FDA Enforcement Rep 2004 May 19.
A5716 FDA has designated this Class II Recall No. Z-0991-04 for certain Cardiac Science AEDs. The
batteries in the AEDs may contain an incorrect fuse, which could open and prevent the AED from
functioning. The manufacturer initiated a recall by letter dated May 10, 2004. Verify that you have
received the May 10, 2004 notification letter, replacement battery, battery installation instructions,
and shipping box with prepaid postage from Cardiac Science. Identify any affected product in your
inventory. Using the instructions included with the notification letter, replace all affected AED
batteries with the replacement batteries provided by the manufacturer. Source: FDA Enforcement
Rep 2004 Jun 9; Manufacturer.
A5734 FDA has designated this Class II Recall Nos. Z-1033/1034-04 for certain Cardiac Science
AEDs.The AEDs may contain defective or marginal high-voltage capacitors, which may prevent the
device from delivering optimum defibrillation therapy during use. The manufacturer states that the
device’s monthly self-test should alert users to a defective capacitor. If an affected AED fails the self-
test, the AED Rescue-Ready nonvolatile indicator, which is located on the device's upper-right
corner, will turn from green to red. The device will then beep and display “call for service.” However,
the firm adds that a self-test may not detect a defective capacitor. In this case, the AED would take
more time to charge and could fail to provide adequate therapy when needed. The manufacturer
initiated a recall by letter dated June 22, 2004. Verify that you have received the June 22, 2004,
letter, list of affected AED serial numbers, and return authorization number from Cardiac Science.
Using the list of affected AED serial numbers, identify any affected product in your inventory. The
manufacturer will test, repair, and return affected AEDs within 30 days of receipt free of charge.
Source: FDA Enforcement Rep 2004 Jun 30; letter submitted by manufacturer.
A5938 Access CardioSystems automated external defibrillators (AEDs) with serial numbers 075180
through 084760 may exhibit 1 or both of 2 problems: the shock delivery circuit may fail and/or the
AED may turn on unexpectedly. If the shock delivery circuit fails, the AED cannot deliver additional
defibrillation shocks. Additionally, the on/off button may become inoperative after the device turns
on unexpectedly; therefore, the AED may not defibrillate. The malfunctions appear to have risen
from a latent defect in some components. An investigation is ongoing to determine the root cause of
the malfunction. Access CardioSystems is discontinuing the manufacture and support of all its AED
models, is no longer accepting orders for disposable parts, and is ceasing operations. The
manufacturer initiated a recall by letter dated November 3, 2004. Verify that you have received the
November 3, 2004 letter and response form from Access CardioSystems (these materials are also
available online at http://www.accesscardiosystems.com). The manufacturer states that users should
immediately discontinue use of units with the affected serial numbers and remove them from
service. Source: Access CardioSystems. Urgent recall notice—immediate action required: Access
CardioSystems, Inc.’s AccessAED and AccessALS automated external defibrillators [online]. 2004
Nov 3 [cited 2004 Nov 9]. Available from Internet: http://www.accesscardiosystems.com/recall.pdf;
Manufacturer.
A6013 In the referenced Action Item (A5938), it was reported that Access CardioSystems is
discontinuing the manufacture and support of all its automated external defibrillator (AED) models,
is no longer accepting orders for disposable parts, and is ceasing operations. The U.K. Medicines and
Healthcare Products Regulatory Agency (MHRA) has issued a Medical Device Alert and the Irish
Medicines Board (IMB) has issued a Safety Notice informing international users of the recall. The
above AEDs with serial numbers 075180 through 084760 may exhibit 1 or both of 2 problems: the
shock delivery circuit may fail and/or the AED may turn on unexpectedly. If the shock delivery
circuit fails, the AED cannot deliver additional defibrillation shocks. Additionally, the on/off button
may become inoperative after the device turns on unexpectedly; therefore, the AED may not
defibrillate. Identify and isolate any affected product in your inventory. MHRA and IMB recommend
that all affected AEDs be removed from service and replaced with alternative AEDs. Source: Great
Britain. Medicines and Healthcare Products Regulatory Agency. Access AED, Access PAD, and
Access ALS defibrillators manufactured by Access Cardiosystems Inc. London: Department of
Health; 2004 Nov 23. 4 p. (Medical device alert; no. MDA/2004/051); Ireland. Irish Medicines Board.
AccessAED PAD, AccessAED and AccessALS automated external defibrillator devices. Dublin:
Department of Health; 2004 Nov 26. 3 p. (Safety notice; no. SN2004[10]).
A6018 FDA has designated this Class II Recall No. Z-1472-04 for ZOLL M Series AEDs. Under
certain conditions, a software defect in the AEDs can cause the device to skip the “Press Shock”
prompt after correctly advising the user of a shockable electrocardiogram rhythm, charging, and
enabling/illuminating the shock button. ZOLL states that the AED indicates that it is ready to
discharge but skips the visual screen display and audible “Press Shock” prompt. Under these
circumstances, the AED will properly analyze the patient’s rhythm and prompt the user regarding
the analysis outcome (“Shock Advised” or “No Shock Advised”). Users can deliver treatment by
pressing the shock button. ZOLL states that the “Press Shock” display and audible prompt are
redundant indications of the AED’s status. The firm adds that rescuers typically know that the
device is charged and ready for discharge when the shock button is illuminated and the ready tone is
sounding. Affected AEDs have been in clinical use since October 2001, and to date, ZOLL has
received only 1 report that may be related to this issue. The manufacturer initiated a recall by letter
dated July 27, 2004. Verify that you have received the July 27, 2004, letter and software update
request form from ZOLL. Identify any affected product in your inventory. The firm states that
although it believes that users likely will not notice that the screen prompt and audible prompt are
missing while using the AED and will operate it correctly, ZOLL will provide users with corrected
software if they choose. Only M Series units equipped with the AED feature are affected. Affected
units have a main switch labeled “On” and “Off” or “On,” “Off,” and “Pace.” Units with switches
labeled “Defib,” “Monitor,” and “Off” and “Defib,” “Monitor,” “Pace,” and “Off” are not affected. To
check the software version of your AEDs: (1) Turn the unit on, and note the software version number
displayed in the lower right-hand corner of the display during the self-test, which occurs when the
unit is turned on. (2) If you have 1 of the affected software versions listed above, advise users of the
problem. (3) Instruct users that if the device issues the “Shock Advised” prompt followed by the
charge-ready tone and illumination of the shock button, the shock button should be pressed to
deliver patient treatment. Source: FDA Enforcement Rep 2004 Sep 22; letter submitted by
manufacturer.
A6154 FDA has designated this action Class II Recall Nos. Z-0398/0399-05 for certain Cardiac
Science AEDs. Delivery of the first defibrillation shock in the 3-shock sequence in the AEDs may be
delayed because of charge noise from a defective electronic component. Cardiac Science states that
this charge noise occurs in limited circumstances when the device is placed on a conductive surface.
The manufacturer adds that all U.S. customers have been notified of the action, that the field
correction is 95% complete in the U.S., and that it has received no reports of patient injury or death
related to this issue. The firm initiated a field correction by telephone call on November 12, 2004.
Verify that you have been contacted by Cardiac Science or your distributor. Identify any affected
product in your inventory. The manufacturer recommends that you continue to use the AEDs until
you have received the field correction for affected devices. Source: FDA Enforcement Rep 2005 Feb
16; Manufacturer.
A6186 FDA has designated this recall Class I for Medtronic LIFEPAK 500 AEDs. The AEDs may
display the “connect electrodes” message and fail to analyze the patient’s heart rhythm even if they
are properly attached to the patient, potentially inhibiting therapy if it becomes necessary.
Medtronic has received 54 reports of such incidents; 8 of these incidents could have prevented
patient resuscitation. The manufacturer adds that the affected 1,924 first-generation, monophasic
LIFEPAK 500 AEDs represent an estimated 1% of the LIFEPAK 500 AEDs used worldwide. While
actual field reports account for <1% of patient uses, a theoretical engineering analysis estimates that
this problem may occur in up to 8% of patients. The firm initiated a recall by certified letter dated
February 3, 2005. Verify that you have received the February 3, 2005, certified letter from
Medtronic. Identify any affected product in your inventory. Medtronic is contacting affected
customers to offer advice on using the above AEDs and to schedule replacement of affected product.
The manufacturer states that it will update or replace the above AEDs by March 31, 2005. Until you
receive an update or replacement, the firm recommends that you leave affected product in service.
Source: Medtronic. Medtronic announces voluntary recall of certain monophasic LIFEPAK 500
automated external defibrillators (AEDs) [press release online]. 2005 Feb 25 [cited 2005 Mar 1].
Available from Internet: http://www.medtronic-ers.com/500/; United States. Food and Drug
Administration. Center for Devices and Radiological Health. Medtronic announces voluntary recall
of certain monophasic LIFEPAK 500 automated external defibrillators [press release online]. 2005
Jan 25 [cited 2005 Mar 1]. Available from Internet:
http://www.fda.gov/oc/po/firmrecalls/lifepak02_05.html.
A6239 Source: United States. Food and Drug Administration. Center for Devices and Radiological
Health. Recall—firm press release: Heartsine Technologies, Inc. issues worldwide recall of certain
automatic external defibrillators [online]. 2005 Mar 18 [cited 2005 Mar 23]. Available from Internet:
http://www.fda.gov/oc/po/firmrecalls/heartsine03_05.html.
A6243 The U.K. Medicines and Healthcare Products Regulatory Agency (MHRA) has issued a
Medical Device Alert warning healthcare workers that Medtronic LIFEPAK 500 AEDs may not
recognize a connection between their electrodes and the patient, potentially impeding analysis and
inhibiting therapy if it becomes necessary. In such situations, affected devices display a “connect
electrodes” message even if they are properly attached to the patient. This problem appears to occur
when patient impedance is at the low end of the AED’s range, which is 30 to 300 Ω according to
device specifications. MHRA recommends the following: (1) Notify all AED users at your facility of
this issue; (2) identify and isolate any affected product in your inventory by comparing your AED
serial numbers with the list of affected serial numbers (available online at MHRA’s Web site at
http://www.mhra.gov.uk or at the manufacturer’s Web site at http://www.medtronic-ers.com/500). If
you possess affected AEDs and do not have alternative models, the manufacturer recommends that
you continue to use the affected AEDs; (3) contact the manufacturer to schedule replacement of
affected product. Source: Great Britain. Medicines and Healthcare Products Regulatory Agency.
Medtronic LIFEPAK 500 monophasic automated external defibrillator manufactured from March to
May 1997. London: Department of Health; 2005 Mar 23. 3 p. (Medical device alert; no.
MDA/2005/020).
A6306 The Australian distributor initiated a recall by safety alert and letter dated February 18,
2005. The U.S. distributor initiated a recall by press release and Urgent Device Recall Notification
letter dated April 28, 2005. FDA has designated this recall Class I Recall No. Z-0805-05 for certain
Laerdal defibrillator adapter cables. The Australian Therapeutic Goods Administration recently
received 2 reports of patient death after defibrillation failure during use of Heartstart 4000
defibrillators with Heartstart 3000 electrode pads. After testing of the above defibrillators and pads
for malfunctions, the manufacturer determined that the problem was caused by breakage of an
adapter cable from “wear and tear”; the cable was being used to make the defibrillator and pads
compatible. Although both the above defibrillators and the above electrodes function correctly and
are not subject to this recall, the preshift checking procedures described in the Heartstart 4000
defibrillator owner’s manual are not suitable for checking the system when it is equipped with an
adapter cable and will not alert the user to a broken adapter cable. Laerdal confirms that the above
cables manufactured and distributed in the U.S. and other parts of the world are subject to the same
problems. For U.S. customers, verify that you have received the April 28, 2005, Urgent Device Recall
Notification letter, “Supplemental Information—Questions and Answers” sheet, receipt
acknowledgment notification, and customer ship history/acknowledgment form from Laerdal and the
firm’s recall contractor, NNC Group. For Australian customers, verify that you have received the
February 18, 2005, safety alert and/or Recall for Product Correction letter and “Not for Clinical Use”
labels from Laerdal. (Note: Customers in other countries will have received notices from the Laerdal
divisions within their respective countries.) Identify, isolate, and immediately discontinue clinical
use of any affected product in your inventory. Source: Australia. Therapeutic Goods Administration.
Recall for product correction of Laerdal patient cable adapters (Laerdal cat # 920650). TGA News
2005 Apr; No. 46; FDA Enforcement Rep 2005 May 18; letter submitted by U.S. distributor.
A6361 FDA has designated this recall Class I Recall No. Z-0806-05 for certain Welch Allyn MRL
automated external defibrillators (AEDs). These units may fail to analyze the patient’s
electrocardiogram and deliver appropriate therapy, possibly delaying treatment and/or resuscitation
and activating the “Defib Comm” error message. The manufacturer has determined that the failure
is caused by radio-frequency interference that is generated inside the defibrillators by an
intermittent electrical short circuit between the connector and the external housing of the device.
The electrical short circuit is created when an impact to the exterior of the defibrillator causes the
circuit board connector to perforate an insulation shield. The manufacturer states that the problem
arises only when the above combination of factors necessary to cause electrical short circuits occurs.
The firm has received 12 complaints related to this problem, including 1 report in which the failure
may have prevented resuscitation. The manufacturer initiated a recall by Urgent Medical Device
Recall letter dated April 28, 2005. If you have any of these devices, verify that you have received the
April 28, 2005, Urgent Medical Device Recall letter and response form from Welch Allyn MRL.
Identify any affected product in your inventory by locating the serial and part numbers on the lower
right corner of the back panel of the defibrillator. Source: Letter submitted by manufacturer; United
States. Food and Drug Administration. Center for Devices and Radiological Health. Medical device
recalls. Class I recall: Welch Allyn Co., AED 20®, automatic external defibrillator [online]. 2005 May
13 [cited 2005 May 16]. Available from Internet: http://www.fda.gov/cdrh/recalls/recall-042805.html;
United States. Food and Drug Administration. Center for Devices and Radiological Health. MRL,
Inc. a Welch Allyn company issues a voluntary worldwide recall of selected AED20 automatic
external defibrillators [press release online]. 2005 May 12 [cited 2005 May 16]. Available from
Internet: http://www.fda.gov/oc/po/firmrecalls/mrl05_05.html; FDA Enforcement Rep 2005 May 18.
A6436 The U.K. Medicines and Healthcare Products Regulatory Agency (MHRA) has issued a
Medical Device Alert warning for certain Laerdal Medical adapter cables that may fail and prevent
defibrillation. MHRA has received 2 reports of patient death in Australia in which broken adapter
cables exhibiting “wear and tear” prevented the defibrillators from delivering a shock. Further
investigation showed that the adapter cables were not included in the preshift checking procedures
when a 50 Ω test load was used and were therefore not tested before the device was used. The
manufacturer initiated a recall to U.K. customers by Advisory Notice 2005-R-01 dated April 18,
2005. For more information about the manufacturer-initiated worldwide recall, see Action Item
Accession No. A6306 dated May 27, 2005. Verify that you have received the April 18, 2005, advisory
notice and return form from Laerdal; the letter and form are also available as an appendix to MHRA
Medical Device Alert No. MDA/2005/032. Identify, isolate, and immediately discontinue clinical use
of any affected product in your inventory. Laerdal states that the above cables are now intended for
training purposes only. If you do not intend to use the device for training purposes, immediately
discard the cables and record the number of discarded cables on the return form. If your facility
chooses to keep the adapter cables for training purposes, clearly label them “NOT FOR CLINICAL
USE” and record the number of labeled cables on the return form. Source: Great Britain. Medicines
and Healthcare Products Regulatory Agency. Defibrillator—Laerdal adaptor cable, product code
920650. London.
Supplier information
Burdick
Burdick Inc, A Quinton Co [105481]
500 Burdick Pkwy
Deerfield, WI 53531
Phone: (608) 764-7179 (800) 777-1777 Fax: (608) 764-7188
Internet: http://www.burdick.com
E-mail: info@burdick.com
Cardiac Science
Cardiac Science Inc [344498]
1900 Main St Suite 700
Irvine, CA 92614-7317
Phone: (949) 797-3800 (888) 274-3342 Fax: (949) 951-7315
Internet: http://www.cardiacscience.com
E-mail: rcohen@cardiacscience.com
Defibtech
Defibtech LLC [435457]
753 Boston Post Rd Suite 102
Guilford, CT 06437
Phone: (203) 453-6654 (866) 333-4248 Fax: (203) 453-6657
Internet: http://www.defibtech.com
Email: sales@defibtech.com
HeartSine
HeartSine Technologies Inc [412550]
940 Calle Amanecer Suite E
San Clemente, CA 92673
Phone: (949) 218-0092 (866) 478-7463 Fax: (949) 218-0093
Internet: http://www.heartsine.com
E-mail: info@heartsine.com
Metrax
Metrax GmbH [172393]
Reinwaldstrasse 22
D-78682 Rottweil
Germany
Phone: 49 (741) 2570 Fax: 49 (741) 257235
Internet: http://www.primedic.de
E-mail: metrax.vertrieb@metrax.de
Philips Medical Systems
Philips Medical Systems, Cardiac & Monitoring Systems Div [397917]
3000 Minuteman Rd Mailstop 101
Andover, MA 01810
Phone: (978) 687-1501 (800) 934-7372 Fax: (800) 947-3299
Internet: http://www.medical.philips.com
Philips Medical Systems (Asia Pacific), Cardiac & Monitoring Systems Div [398048]
24/Fl Cityplaza One 1111 King's Road
Taikoo Shing
People's Republic of China
Phone: 852 31977777 Fax: 852 25069261
Internet: http://www.medical.philips.com
Philips Medical Systems (Europe), Cardiac & Monitoring Systems Div [398047]
Herrenberger Strasse 124
D-71034 Boeblingen
Germany
Phone: 49 (7031) 4641552 Fax: 49 (7031) 4644096
Internet: http://www.medical.philips.com
E-mail: pmscc@philips.com
Progetti
Progetti srl [272310]
via Bruno Buozzi 28
I-10024 Moncalieri TO
Italy
Phone: 39 (011) 644738 Fax: 39 (011) 645822
Internet: http://www.progettimedical.com
E-mail: info@progettimedical.com
Schiller
Schiller AG [162079]
Altgasse 68
CH-6341 Baar
Switzerland
Phone: 41 (41) 7664242 Fax: 41 (41) 7610880
Internet: http://www.schiller.ch
E-mail: sales@schiller.ch
France
Phone: 33 (3) 88633600 Fax: 33 (3) 88941282
Internet: http://www.schiller-medical.com
E-mail: info@schiller.fr
Welch Allyn
Welch Allyn Inc [101850]
4341 State Street Rd PO Box 220
Skaneateles Falls, NY 13153-0220
Phone: (315) 685-4100 (800) 535-6663 Fax: (315) 685-4091
Internet: http://www.welchallyn.com
E-mail: info@mail.welchallyn.com
Note: The data in the charts derive from suppliers’ specifications and have not been verified
through independent testing by ECRI or any other agency. Because test methods vary, different
products’ specifications are not always comparable. Moreover, products and specifications are subject
to frequent changes. ECRI is not responsible for the quality or validity of the information presented
or for any adverse consequences of acting on such information.
When reading the charts, keep in mind that, unless otherwise noted, the list price does not reflect
supplier discounts. And although we try to indicate which features and characteristics are standard
and which are not, some may be optional, at additional cost.
For those models whose prices were supplied to us in currencies other than U.S. dollars, we have
also listed the conversion to U.S. dollars to facilitate comparison among models. However, keep in
mind that exchange rates change often.