Medtronic Announces Additional Devices Affected in Voluntary Recall of Certain Monophasic LIFEPAK 500 Automated External Defibrillators
Affected Devices Were Distributed WorldwideApr 22, 2005 | Genetic Engineering News
Medtronic, Inc. today announced that it has identified an additional 396 monophasic LIFEPAK(R) 500 automated external defibrillators (AEDs) to be included in a voluntary recall originally announced on Feb. 25, 2005. The company will be contacting the owners of the additional 396 devices that are in use worldwide.
The affected AEDs may continue to display a "connect electrodes" message and may not analyze the patient's heart rhythm even when the electrodes are properly connected. Failure to analyze the patient's heart rhythm will inhibit defibrillation, if it is needed.
The company has already completed the updates or upgrades to the devices originally identified as affected. The company plans to complete the update or upgrade to the additional affected devices by May 31, 2005. Affected AEDs may remain in service, and customers with devices in this additional group are currently being contacted with recommendations for use and replacement schedules. Only certain monophasic LIFEPAK 500 AEDs manufactured in 1997 are included in this action.
The U.S. Food and Drug Administration (FDA) was apprised of the additional devices the week of April 18, 2005. FDA classified the original action February 24, 2005 as a Class I recall. The FDA defines Class I as a situation in which there is reasonable probability that the use of or exposure to the product will cause serious adverse health consequences or death.
The LIFEPAK 500 is used by first responders such as firefighters, police and others trained in CPR/AED use and are first to arrive at the scene of a cardiac incident but do not have significant medical training.