More external defibrillators/monitors are being recalled by the Food and Drug Administration (FDA) because of a failure on the power supply that can render the device unable to deliver lifesaving therapy. The Class 1 recall includes 42,943 LIFEPAK 20 and LIFEPAK 20e external defibrillators/monitors manufactured by Physio-Control, Inc. between July 31, 2002 and September 19, 2007, and distributed to customers between September 16, 2002 and September 27, 2007.

LIFEPAK 20 and LIFEPAK 20e defibrillators/monitors are designed to be used by trained medical personnel in hospitals and clinic settings to monitor patient heart rhythms and to treat patients experiencing cardiac arrest. The defect involves a failure on the power supply assembly that can result in either “No DC power” or “No DC  or AC power.” A failure of DC, or battery power, can result in the inability to deliver defibrillation therapy if the device will not turn on using DC power and no AC, or line power, is available.

Class 1 recalls are the most serious type of recall the FDA can issue and involves situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.

In April 2010, The FDA announced a Class 1 recall on LIFEPAK 15 monitors/defibrillators because the devices could shut off unexpectedly by themselves.

Physio-Control, Inc., began mailing notification letters to affected customers regarding the latest recall on May 26, 2010, and said it would update all affected power supplies. Customers are advised to keep the defibrillators in service and follow recommended daily operator checklist steps while service updates are scheduled. Any adverse events with this or any other medical device should be reported to the FDA MedWatch Adverse Event Reporting Program at www.FDA.gov/MedWatch.