About 43,000 Lifepak 20 and Lifepak 20e defibrillators have been recalled because the power supply could fail; a malfunction that may have led to the death of at least one patient.
The Lifepak 20 defibrillator recall was announced by the FDA on July 2, but Physio-Control Inc., a subsidary of Medtronic that manufactures the defibrillators, began alerting customers to have their devices checked frequently for power supply problems and offering repairs on May 27.
The FDA declared the action a Class 1 medical device recall, which means that the problem is likely to cause serious injury or death. Physio-Control reports that it has received at least one report of a patient in Australia dying in connection with the Lifepak 20 power supply problems, but has not been able to investigate the report to discover the details of the death.
The Lifepak 20 defibrillators have a dual power supply, and are capable of running off of AC line power or a DC battery. A defect in the devices’ construction can cause the battery power to fail, meaning that if there is no place to plug the defibrillator in, there may be no way to deliver life-saving electrical shocks to patients in need.
The Lifepak 20 recall affects an estimated 42,943 Lifepak 20 and Lifepak 20e External defibrillator/monitors sold worldwide between September 16, 2002 and September 27, 2007. Registered owners have been contacted by mail, and owners who have not been notified can use the serial number on the bottom of the device to search on the Physio-Control announcement to see if their defibrillator is affected.
Physio-Control has recommended that owners follow recommended daily Operator Checklist steps to ensure the defibrillators are working properly until repairs can be made. The company says it plans to update the power supplies for every device affected within a year, and the power supplies for all Lifepak 20 and 20e devices within two years.
This is the second recall of Lifepak defibrillators this year, and both have been due to power problems. In late April, Physio-Control recalled an unspecified number of Lifepak 15 defibrillators by serial number because a short circuit could cause the device to turn on and off by itself or prevent it from being turned on when needed.