FDA: Defibtech's DBP-2800 Battery Packs Recalled
Battery packs used in Lifeline and ReviveR AEDs recalled due to four reports of malfunction
THURSDAY, June 10 (HealthDay News) -- Defibtech has alerted customers of a voluntary recall of 5,418 DBP-2800 Battery Packs used in the Lifeline Automatic External Defibrillator (AED) and ReviveR AED, as these AEDs may incorrectly recognize an error condition during charging for a shock and discontinue the charge, not providing therapy when the defected battery packs are used.
The voluntary recall was issued after the company received four reports of the malfunction from customers. The DBP-2800 battery packs affected by this recall shipped prior to June 4, 2007, and have been distributed globally to fire departments, emergency medical systems, health clubs, schools, and various other organizations. The company has issued recommendations for the end user to follow until the battery pack can be replaced, allowing the battery pack to remain in service, which is being mailed to all affected customers and is available at www.defibtech.com.
The U.S Food and Drug Administration labeled this recall as Class I, recommending customers report any adverse events and/or quality problems associated with these devices to the FDA's MedWatch Adverse Event Reporting Program, or calling 1-800-332-l088.
"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," according to a recent press release from Defibtech.