Class I Recall for LIFEPAK 20, 20e Defibrillator/Monitors

Disclosures

July 06, 2010

July 6, 2010 (Rockville, MD) — The US Food and Drug Administration (FDA) has issued a class 1 recall of the LIFEPAK 20 and LIFEPAK 20e external defibrillator/monitors (Physio-Control, Redmond, WA) [1]. The recall affects approximately 43 000 devices distributed worldwide over a five-year period starting in September 2002.

The LIFEPAK 20/20e has a dual power-supply system that operates on AC (line) and/or DC (battery) power. The reason for the recall is a failure in the power-supply assembly that results in "No DC power" or "No DC or AC power." A malfunction of battery power can result in a failure to deliver defibrillation therapy if the device does not turn on using DC power and if no AC power is available.

As a result of these problems, the company began mailing notification letters to all affected customers and plans to update the power-supply assemblies. On its website, the company notes that failures of the AC or DC power supply can be detected during routine daily checks and recommends that the daily "operator's checklist" steps, in accordance with the operating instructions, are followed.

In April, as reported by heartwire , the FDA issued a class 1 recall of the LIFEPAK 15 monitor/defibrillator because of the possibility the device would power off and on by itself, would power off and not turn back on, would turn off and require the operator to turn it back on, or would stay powered on and would not power off. In September 2009, a class 1 recall of the LIFEPAK CR Plus automated external defibrillator was issued because a humid environment was thought to cause the devices to improperly analyze the heart rhythm. And finally, in June 2005, the FDA issued a warning letter to Medtronic describing persistent problems with the cable connectors and wiring on the company's LIFEPAK 12 external cardiac defibrillators.

Medtronic has partnered with Physio-Control since 1998 to manufacture and distribute these devices.

Class 1 recalls are the most serious type of recall and involve situations in which there is a reasonable probability that the use of these products will cause serious injury or death. According to the FDA, healthcare professionals should report adverse events or quality problems related to the LIFEPAK 20/20e monitor/defibrillator to the MedWatch Safety Information and Adverse Event Reporting Program.

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