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Urgent Medical Device Recall: LifePak CR Plus and LifePak Express Defibrillators - For Health Professionals
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(PDF Version - 59 K)Contact: Marketed Health Products Directorate (MHPD)
The Health Products and Food Branch (HPFB) posts on the Health Canada web site safety alerts, public health advisories, press releases and other notices as a service to health professionals, consumers, and other interested parties. These advisories may be prepared with Directorates in the HPFB which includes pre-market and post-market areas as well as market authorization holders and other stakeholders. Although the HPFB grants market authorizations or licenses for therapeutic products, we do not endorse either the product or the company. Any questions regarding product information should be discussed with your health professional. This is duplicated text of a letter from Physio-Control, Incorporated, a division of Medtronic of Canada, Limited. |
Health Canada Endorsed Important Safety Information on LIFEPAK CR Plus and LIFEPAK EXPRESS defibrillators |
July 31, 2008
| Subject: | URGENT MEDICAL DEVICE RECALL - LIFEPAK CR® Plus defibrillator / LIFEPAK EXPRESS® defibrillator |
Dear Customer:
Physio-Control, Incorporated, a division of Medtronic, Incorporated is notifying customers of a recall for LIFEPAK CR Plus and/or LIFEPAK EXPRESS automated external defibrillators (AED) manufactured between November 2006 and March 2008. These AEDs contain a specific internal flex cable that may be susceptible to failure and could cause a short, preventing the AED from powering on. Failure to power on will prevent delivery of therapy to a patient.
Physio-Control recommends customers to immediately inspect their AED for this issue by pressing the On/Off button to verify the device will power on and that voice prompts begin. See full recommendations below. To determine whether the devices are affected by this action, customers may visit the 
company's website by entering the serial numbers of the devices.
Recommendations:
- Immediately verify your AED powers on and voice prompts begin.
After verification, press and hold the On/Off button for approximately two seconds to turn the AED off. - Keep your AED in use and perform monthly inspections that include the additional AED power on test. A monthly inspection is consistent with the LIFEPAK CR Plus/LIFEPAK EXPRESS AED Operating Instructions.
- If "OK" is visible on the Readiness Display and the AED powers on, it is ready for use.
- If, at any time, the AED does not power on or if any other indicator displays (i.e. ,
, 
, or 
), please immediately call 1-888-879-0977.
A Physio-Control representative will contact you within 90 days to make arrangements regarding the correction of all your potentially affected defibrillator(s).
In the interim, please fill out the Confirmation Sheet indicating that you have inspected all affected AEDs and verified that they power on and that voice prompts begin. Follow the instructions on the sheet to return the completed form to 905-826-5629.
Managing marketed health product-related adverse incidents depends on health care professionals and consumers reporting them. Reporting rates determined on the basis of spontaneously reported post-marketing adverse incidents are generally presumed to underestimate the risks associated with health product treatments. Any incident or other serious or unexpected adverse incidents associated with the use of a LIFEPAK CR Plus and/or LIFEPAK EXPRESS automated external defibrillator should be reported to Medtronic, or to Health Canada at the following address:
Medtronic of Canada Limited Any suspected adverse incident can also be reported to: The Medical Devices Problem Report Form and Guidelines can be found on the Health Canada web site. For other inquiries related to this communication, please contact Health Canada at: |
If you have any questions regarding this notification, please call Technical Support at 1-888-879-0977, weekdays between 8:30 a.m. and 5:00 p.m. (Eastern Time), or visit our website. Medtronic is committed to ensuring our products meet the highest quality standards and that our customers are fully supported.
Sincerely,
PHYSIO-CONTROL INCORPORATED., a division of Medtronic
original signed by
Robert Levo,
Director, Physio-Control Canada
[FIRST NAME], [LAST NAME]
[CLINIC NAME]
[ADDRESS]
[CITY], [PROVINCE], [POSTAL CODE]
CONFIRMATION SHEET
LIFEPAK ® Plus AED
LIFEPAK EXPRESS® AED
Reports Issue
Internal flex cable
To confirm you have received this important information, please complete this page and fax back to Physio-Control attention Denis Gosselin at 1-866-430-0533.
I have read the Medtronic notification and understand the issue regarding the LIFEPAK CR® Plus and LIFEPAK EXPRESS® AED. I understand the recommendations outlined in the letter.
Please Print Your Name_____________________________________________
Signature________________________________________________________
Date____________________________________________________________
SIGN, DATE AND FAX COMPLETED SHEETS TO PHYSIO-CONTROL ATTENTION DENIS GOSSELIN AT 1-866-430-0533.
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