Philips Healthcare

FIELD CHANGE ORDER Service

Issued by : ECR, Michelle Thompson FCO Ref No. : FCO86100182A
Supersedes : Date : 19-JUN-2017
TITLE : FCO86100182A Release of HeartStart MRx Monitor/Defibrillator Software Resolution for
FCO86100179 T.00.06 and F.03.07 Power CPLD 15

CLASSIFICATION:
_X_ Mandatory Action
___ Action for Performance – Proactive
___ Action for Performance – Retrofit on Failure
___ Service Recommendation
NOTE: This FCO provides the corrective action for FCO86100179 (Symptom 2 in the FCO and
Behavior Description 2 in the FSN). A software upgrade for T.00.06 and F.03.07 is available on
InCenter. You may download the software to your existing 64MB or 256MB data cards.

APPLIES TO:

Geography : Worldwide

Traceable Item Identification PMS Number: Part Number:

861288 M3535A
989803132391 M3535ATZ
861289 M3536A
989803132401 M3536ATZ
861464 M3536M
861465 M3536MC
861481 M3536M2
861482 M3536M3
861483 M3536M4
861484 M3536M5
861491 M3536M6
860396 M3536M7
860397 M3536M8
860398 M3536M9
Range of Serial Numbers See UAL86100182
Commercial (Sales) Product Number PMS Number: Part Number:
861288 M3535A
861289 M3536A
861464 M3536M
861465 M3536MC
861481 M3536M2
861482 M3536M3
861483 M3536M4
861484 M3536M5
861491 M3536M6
860396 M3536M7
860397 M3536M8
860398 M3536M9

(Template Document Number: A-Q2920-00108-T1, Rev. R)

Field Change Order Document Number FCO86100182A Rev. A Page 1 of 5
LIST OF PAGES & DRAWINGS:
Body of FCO Pages 1 – 4
Addendum A – FCO Action Notification Report (ANR Page 5
Form)

INTRODUCTION:
Symptom : Philips has identified the possibility of abnormal device behaviors on the HeartStart MRx
Monitor/Defibrillator. Under exceptionally rare circumstances, the device may exhibit the
following behaviors:
1. If the pins that connect the battery to the device have become damaged or full of debris,
it could result in a poor electrical connection. The device may not power on or may
repetitively reboot when on battery power only.
2. After unplugging the device from AC mains, when operating with a single battery as the
sole source of power, there are two abnormal behaviors of the HeartStart MRx
Monitor/Defibrillator that may occur:
a. After the user depresses the charge button, the device attempts to charge,
and after approximately 20 seconds, generates the “Shock Equipment
Malfunction” error message and is unable to deliver shock therapy.
b. Pacing may cease without warning. These device behaviors continue until the
unit is reset.

Either potential problem could potentially delay monitoring or therapy.

Cause : Following an internal complaint database search, Philips found that:

1. After unplugging the device from AC mains, Two separate events must coincide for the
abnormal behavior to occur:
a. When the user unplugs AC power, the MRx inappropriately remains in the “AC
mains” operating mode and fails to switch to the “battery only” mode.
b. and the battery is at least partially depleted.

These behaviors do not happen when the device is operating on two batteries. There have
been no reports of these behaviors when the device is unplugged from DC power. These
device behaviors continue until the unit is reset.

Remedy : As a remedy, Philips is:

Providing measures to correct the abnormal device behavior related to charging and
pacing after disconnecting the device from AC mains. The corrective action is to
upgrade software T.00.06 and F.03.07 to include Power CPLD 15. You may download
the software from InCenter to your existing 64MB or 256MB data cards. Please refer to
the instruction in the Procedures section of this FCO for the correct steps.

If hardware or software was installed recently on the device, verify the Power CPLD is NOT
15, prior to downloading software in the Procedures section of this FCO. There is no need
to reload software if the CPLD is already version 15.

MANPOWER / TIME TO COMPLETE:

Implementation:
0.75 Hours
1 Engineer

Implementer: Please check appropriate box or boxes:

 Philips Engineer or Approved Service Provider
Customer
 No Engineer Required
TOOLS & TEST EQUIPMENT:
Refer to HeartStart Service Manual for tools required for Software upgrade.

MODIFICATION KIT / PARTS REQUIRED:

Modification kit: N/A

(Template Document Number: A-Q2920-00108-T1, Rev. R)

Field Change Order Document Number FCO86100182A Rev. A Page 2 of 5
PROCEDURE:
Note: There is no modification kit for this FCO. Instead, there is an applicable Software Support Tool from the
table below to complete the software installation from InCenter. The part number is for information only and not
needed to download updated software from InCenter.

NEW PARTS - SOFTWARE SUPPORT TOOL - InCenter Only

Pre-Hospital Hospital (M3535A)
(M3536A) Military (M3536Mx)
Description Load T.00.06 or Load F.03.07 or
higher higher
12NC 12NC
American English 453564696061 453564695891
Commonwealth
453564696071 453564695901
English
Chinese (Simplified) 453564696191 453564696021
Chinese (Traditional) 453564696221 453564696051
Danish 453564696091 453564695921
Dutch 453564696101 453564695931
Finnish 453564696111 453564695941
French 453564696121 453564695951
German 453564696131 453564695961
Italian 453564696141 453564695971
Japanese 453564696151 453564695981
M3536J
Korean 453564696161 453564695991
Norwegian 453564696171 453564696001
Polish 453564696181 453564696011
Portuguese 453564696081 453564695911
Russian 453564696231 N/A
Spanish 453564696201 453564696031
Swedish 453564696211 453564696041

Steps for the Field Service Engineer (FSE) or bench technician to complete Service Work Order (SWO):

1. To verify software needs update:

 Reference the Service Manual > Printing the Device Information (Steps 1 – 5)

NOTE: If CPU Board > Power CPLD is NOT 15, than you must update the device software.
If the Power CPLD version is already 15, then the software update has already been completed.
(Skip to step 5)

2. To access the software from InCenter:

 Reference the Service Manual > Downloading Software from the InCenter (Steps 1 – 8)
 Load the appropriate title:
HeartStart Mrx Upgrade to P-CPLD15 and F.03.07 Software (M3535A, M3535M)
HeartStart Mrx Upgrade to P-CPLD15 and T.00.06 Software (M3536A)

3. To install the software from the data card to the MRx:

Reference the Service Manual > Software Installation (Steps 1 – 7)

NOTE: It is normal for the device to reboot two times during software update

(Template Document Number: A-Q2920-00108-T1, Rev. R)

Field Change Order Document Number FCO86100182A Rev. A Page 3 of 5
 NOTE: On extraordinarily rare occasion, the device may appear to hang for up to 25 minutes. If
this occurs, DO NOT INTERRUPT THE SOFTWARE UPDATE. This behavior has only been seen
in a testing environment and is exceptionally rare. Should the update not resume automatically
please replace the Processor PCA (under warranty) and restart the software update.

4. To verify software installation:

Reference the Service Manual > Installation Completion (Steps 1 – 3)

5. Mandatory verification effectiveness check to include empirical evidence:

 Reference the Service Manual > Installation Completion
 Print Device Info: CPU Board: Power CPLD must be version 15 after software update
 Reference the Service Manual > Printing the Device Information (Steps 1 – 5)
 Print a strip showing the device information, Options and CPU Board information (see below)
 Mail the strip(s) every two weeks to local Modality Performance Specialist (MPS) for your region. The
Modality Performance Specialist will cross reference serial number on print device info strip with
regions UAL.

The following picture illustrates an example after correct software update and what to provide MPS

6. Close the Service Work Order

Location Category: __X__ On-site __X__ Philips Medical CRC

______ Customer Installable ______ Remote

PARTS DISPOSAL: N/A

______Return ______Scrap ______Other

DOCUMENTATION:
2945-2017-05-03953

(Template Document Number: A-Q2920-00108-T1, Rev. R)

Field Change Order Document Number FCO86100182A Rev. A Page 4 of 5
 Addendum A - FCO ACTION NOTIFICATION REPORT (ANR form)

FCO ACTION NOTIFICATION REPORT (ANR form)

For Key Market use only; do not return to BU/BL.
TITLE: FCO86100182A Release of HeartStart MRx Monitor/Defibrillator Software Resolution for
FCO86100179 T.00.06 and F.03.07 Power CPLD 15
CLASSIFICATION: Mandatory FCO REF. NO.: FCO86100182A

APPLIES TO: See FCO86100182A for “Applies To” information

HOSPITAL / ADDRESS:

LOCATION / FW SITE NO.: SALES ORDER NO. / OA NO.:

PRODUCT NUMBER:

UNIT SERIAL NUMBER:

ACTION ON THIS UNIT WAS: (select one) JOB NO. / SERVICE INCIDENT NO.:

Completed per instruction on

DATE
Completed by the factory prior to delivery

Not completed as this unit is not affected per instruction because: (state reason)

Not completed because: . . . . . . . . . . . . .

Required parts & instructions are received by the customer

Not completed because customer refuses to install FCO: (state reason)

CUSTOMER ACKNOWLEDGEMENT (Required for PROACTIVE ACTIONS only).

The REASON and PURPOSE of this modification has been explained to me.

CUSTOMER NAME (PLEASE PRINT) TITLE

CUSTOMER SIGNATURE DATE

BRANCH SERVICE UNIT /

REGION / SERVICE AREA NO.:
DEALER:

SIGNATURE CUSTOMER SERVICES ENGINEER DATE

SIGNATURE CUSTOMER SERVICES MANAGER MAIL TO: Do not return to BU/BL

(Template Document Number: A-Q2920-00108-T1, Rev. R)

Field Change Order Document Number FCO86100182A Rev. A Page 5 of 5