Cook Medical Europe

COOK
® O’Halloran Road,
National Technological Park,
Limerick, Ireland.
Phone: + 353 61 334440

Urgent Field Safety Notice

C
Commercial name of the affected product: Cook Vacuum Pump™
Fax: + 353 61 334441

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Manufacturer : William A. Cook Australia Pty Ltd

Cook Reference : 2018FA0006 / QCR-82

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Type of Action: Field Safety Corrective Action
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Date: 08 March 2018

Attention: Chief Executive Officer of IVF Unit / Risk Management / Purchasing / Director of Nursing
®
Details on affected devices:

Product Name Reference Part Global Product Lot Numbers

Number Number
Cook Vacuum Pump™ K-MAR-5200 G49275 All lots

Description of the Problem:

During a recent design review of the K-MAR-5200 Vacuum Pump, William A. Cook Australia Pty Ltd
identified that the internal mains wiring does not fully comply with the requirements of the medical
electrical equipment standard IEC60601-1 Edition 3.0.

IEC60601-1 states that conductors and connectors of medical electrical equipment shall be secured or
insulated so that accidental detachment shall not result in a hazardous situation. The K-MAR-5200 mains
wiring is secured, but the mechanism is not considered suitable under IEC60601-1.

The potential hazardous situations which could arise due to K-MAR-5200 mains wiring detaching from the
terminals include;

 Failure of the device to operate.

 Electric shock or burn to the user.

There have been no reports of harm associated to this fault since the release of the device. There has
been one occurrence of a device failing to operate, which resulted in a minor inconvenience to the user.
No harm was reported in this instance.

Field Action:
 Cook Medical is initiating a Field Safety Corrective Action to replace the mains wiring components
in all devices in the field. This will ensure that the devices fully comply with the requirements of
IEC60601-1 Edition 3.0. Any new devices will have the correct mains wiring installed.

Form: F14-00A (R10, CR16-0422) © COPYRIGHT DOCUMENT

 page 2 of 2

 Cook Medical will be replacing the mains wiring for each unit either at your premises or as a back
to base repair. An authorised service agent will contact you to arrange for impacted devices to be
corrected.

 Cook Medical recommends whilst waiting for the device correction that a residual current device
(RCD), also known as a ground fault circuit interrupter (GFCI), ground fault interrupter (GFI), or an
appliance leakage current interrupter (ALCI) is fitted to the mains electricity supply to mitigate the
risk of a hazardous situation.

Advise on action to be taken by the user:

1. Please complete the enclosed Customer Response Form within 5 business days to acknowledge
receipt of this Field Safety Notice Letter.
2. Send the completed Customer Response Form via email to
European.FieldAction@CookMedical.com or alternatively by fax to Cook Medical marked for the
attention of European Customer Quality Assurance (fax number +353 61 334441).
3. Your authorised service agent will contact you to arrange for your device to be corrected.
4. Please report any adverse events to Cook Medical by contacting our Customer Support Department
or your local COOK representative.

Transmission of this Field Safety Notice:

This notice needs to be passed on to all those who need to be aware within your organisation or to any
organisation where the potentially affected devices have been transferred.

Please transfer this notice to other organisations on which this action has an impact.

Please maintain awareness of this notice and resulting action for an appropriate period to ensure
effectiveness of the corrective action.

Contact reference person:

Michael Galvin
Regulatory Affairs Manager
COOK Ireland
O’Halloran Road, National Technology Park, Limerick, IRELAND

Or

Annemarie Beglin
Quality Systems Manager
COOK Medical Europe
O’Halloran Road, National Technology Park, Limerick, IRELAND

Should you have any questions, please feel free to contact us for more information (e-mail:
European.FieldAction@CookMedical.com, phone +353 61 334440).

We confirm that this notice has been notified to the appropriate Regulatory Agency.

Annemarie Beglin
Quality Systems Manager

Form: F14-00A (R10, CR16-0422) © COPYRIGHT DOCUMENT

 Cook Medical Europe

COOK
®
® O’Halloran Road,
National Technological Park,
Limerick, Ireland.
Phone: + 353 61 334440
Fax: + 353 61 334441
FIELD ACTION CUSTOMER RESPONSE FORM

Field Action reference no.: 2018FA0006 / QCR-82

Affected device: K-MAR-5200 (G49275)

Please indicate the following:

Customer Number: ___________________

Customer Name: ____________________________________________________

Street Address: ____________________________________________________

City, ZIP: ____________________________________________________

Completed by: ____________________________________________________

Department: ____________________________________________________

Phone Number: ____________________________________________________

(Please Print)

Please complete the following:

Actions Taken:

1. I have received the 2018FA0006 Field Safety Corrective Action letter

and understand the instructions provided in the letter. Yes No

2. I have examined my inventory and have no affected product. Yes No

3. I have examined my inventory and have affected product to be corrected Yes No

by an authorized service agent

4. I have experienced an adverse event associated with the affected Yes No

product

5. If yes, please explain the adverse event below:

Form: F14-00B (R10, CR16-0422) © COPYRIGHT DOCUMENT

COOK FSCA Customer Response Form page 2 of 2

**If you are a distributor, have your customers been notified of this Field Safety Corrective Action?

Yes No

Signed: __________________________________________ Date: __________________

Please return the completed Customer Response Form to by e-mail to

European.FieldAction@cookmedical.com or by fax to + 353 61 334441.

Form: F14-00B (R10, CR16-0422) © COPYRIGHT DOCUMENT