Physio-Control Lifepak External Defibrillators Named in Class I RecallJul 6, 2010 | Parker Waichman LLP
Medtronic Inc.’s Physio-Control unit has issued a class I recall for Lifepak 20 and Lifepak 20e external defibrillator/monitors. The recall is being issued because of a potential battery-power problem.
According to the Wall Street Journal, one patient may have died as a result of the battery power problem. The death occurred in Australia four years ago, according to a Physio-Control spokesperson. The company was unable to recover the device to confirm the problem and doesn’t know specifics about the situation, the Journal said.
The recall involves nearly 43,000 Lifepak 20 and Lifepak 20e defibrillator/monitors. They were manufactured from July 31, 2002 to September 19, 2007, and distributed worldwide between September 16, 2002 and September 27, 2007.
These devices are designed for use by trained medical personnel in hospitals and clinic settings to monitor patient heart rhythms and to treat patients experiencing cardiac arrest.
According to the recall notice, a failure on the power supply assembly can result in either “No DC power” or “No DC or AC power”. A failure of DC (battery) power can result in the inability to deliver defibrillation therapy if the device will not turn on using DC (battery) power and no AC (line) power is available.
Physio-Control began mailing notification letters to affected customers on May 26, 2010. All affected power supplies will be updated. Customers are advised to keep the defibrillators in service and follow recommended daily Operator Checklist steps while service updates are scheduled.
Class 1 recalls are the U.S. Food & Drug Administration’s most serious type of recall and involve situations in which there is a reasonable probability that use of a device will cause serious adverse health consequences or death.