Defibtech LLC is voluntarily recalling 5,418 DBP-2800 battery packs used in the Lifeline AED and ReviveR AED (semi-automatic external defibrillators) due to a potential failure to deliver therapy when the battery pack is used with an AED.
The FDA has determined that this action is a Class I recall.
According to the company, in rare instances when the AED is used with an affected battery pack, the AED may falsely detect an error condition during charging for a shock, then cancel charge and not provide therapy. Defibtech decided upon the recall after learning of four reports from end users of this malfunction during patient use.
The recall affects all DBP- 2800 Battery Packs shipped prior to June 4, 2007.
The company has identified recommendations for the end customer to follow until the battery pack has been corrected (available online), which allows the battery pack to remain in service. Defibtech will provide customers with a free battery pack update card to address this issue for all affected battery packs. The update is expected within the next two weeks.
A copy of these recommendations is being mailed to all affected customers. For additional information, contact Defibtech at (877) 453-4507.