A Medical Device Daily
Medtronic Physio-Control (Redmond, Washington) reported that it has identified an additional 396 monophasic Lifepak 500 automated external defibrillators (AEDs) to be included in a voluntary recall originally reported on Feb. 25 (Medical Device Daily, March 1, 2005). The company will be contacting the owners of the additional 396 devices that are in use worldwide, it said.
In its original statement, Medtronic said it had received 54 incident reports related to this specific group of Lifepak 500 AEDs, including eight instances “where it may have prevented patient resuscitation,” corresponding, it said, “to less than 1% of patient uses.”
That original action affected 1,924 first-generation Lifepak 500 AEDs manufactured in 1997, or about 1% of Lifepak 500 units now 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 completed the updates or upgrades to the devices originally identified as affected. It said it plans to complete the update or upgrade to the additional affected devices by May 31.
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.
The FDA was apprised of the additional devices the week of April 18. The FDA classified the original action 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.