More than 5,400 Defibtech rechargeable defibrillator battery packs are being recalled due to a defect that may result in the batteries not providing the power for life-saving electric shocks when needed.
The Defibtech defibrillator battery recall was announced on June 9 by FDA, following a June 3 announcement by the Defibtech, LLC. The batteries are in use in Lifeline AED and ReviveR AED semi-automatic external defibrillators (AED).
In certain cases, when the battery is connected to the AED, the device may falsely detect an error while charging up to provide a shock to the patient and then deactivate the charge. The company has received at least four reports of this malfunction occurring when patients needed defibrillation. Defibtech did not indicate whether the patients in those situations recovered.
The FDA has classified the defibrillator recall as a Class 1 Medical Device Recall, meaning that the defect is likely to result in serious injury or death. It is the most serious form of medical device recall.
According to Defibtech, the defect involves 5,418 DBP-2800 Battery Packs shipped before June 4, 2007. “Lifeline AED” or “ReviveR AED” is printed on the front of the affected devices. The battery packs were distributed worldwide to emergency services providers, schools, health clubs and other organizations.
The company has said it has mailed recommendations to customers on how to use the AEDs with the defective batteries, until the battery pack can be replaced. The company will provide free repair kit to customers. For more information, customers can go to www.defibtech.com/batteryFA.