A type of battery pack used to charge semi-automatic external defibrillators (AED), cardiac devices used to treat adults in a heart attack by automatically delivering an electric shock to the heart if needed to restore normal heart rhythm, are being recalled by the manufacturer because the battery packs may falsely detect an error condition during charging for a shock, then cancel charge and not provide therapy.

The Class 1 recall of Defibtech DBP-2800 Battery Packs used in Lifeline AED and ReviveR AED devices was announced today by the Food and Drug Administration (FDA). A Class 1 recall is the most serious type of recall issued by the FDA and involves situations where there is a potential for serious injury or death. The recall affects all DBP-2800 Battery Packs shipped prior to June 4, 2007. The packs were distributed globally to fire departments, EMS, health clubs, schools and other organizations.

The company has identified recommendations for the end customer to follow until the battery pack has been corrected, which allows the battery pack to remain in service. A copy of these recommendations is being mailed to all affected customers. Defibtech will provide customers with a free battery pack update card to address this issue for all affected battery packs. The correction to the battery pack will be able to be performed at the location where the battery pack is deployed using any DDU-100 series AED and a Defibtech supplied battery pack update card. The battery pack update is expected to be available within the next two weeks. 

Last year, the FDA issued separate recalls on AEDs made by Welch Allyn and Phillips Heartstart Fr2+ because of low energy readings and memory chip defects. In November 2009, the FDA announced it was investigating AEDs and external biphasic defibrillators, monitor/defibrillators due to reports of ineffectiveness.

Healthcare providers who suspect a problem with AEDs are encouraged to report the problem to the FDA at www.FDA.gov/MedWatch/report.htm.