July 2008
URGENT MEDICAL DEVICE RECALL
LIFEPAK CR® Plus defibrillator / LIFEPAK EXPRESS® defibrillator
Dear Customer:
Physio-Control, Inc., a division of Medtronic is notifying customers of a voluntary 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 potentially short, preventing the AED from powering on. Failure to power on will prevent delivery of therapy to a patient. There have been no reports of adverse events for this issue.
We are investigating three confirmed events of this shorting issue occurring during AED testing in the field. In these reports, the AED would not power on although the OK indicator was visible on the Readiness Display. Physio-Control recommends customers 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. An enclosed list identifies your potentially affected AEDs by serial number.
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 poweron 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, please immediately call Physio-Control Technical Support at 1.800.442.1142.
A Physio-Control representative will contact you within 60 days to arrange replacement of all your potentially affected defibrillator(s) at no charge. In the interim, please fill out the enclosed Confirmation Sheet indicating that you have inspected all AEDs listed and have verified that they power on and that voice prompts begin. Follow the instructions on the sheet to return the completed form to Physio.
Physio-Control is committed to ensuring our products meet the highest quality standards and to fully supporting our customers. If you have any questions or would like additional information, please call 1.800.442.1142 weekdays between 6:00 a.m. and 4:00 p.m. (Pacific), or visit our website referenced above.
Sincerely,
PHYSIO-CONTROL INC., a division of Medtronic
Jorge Artiles
Vice President, Quality Assurance