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Defibtech DBP-2800 Battery Packs used in Lifeline AED and ReviveR AED: Recall
Audience: Emergency Medicine
[Posted 06/09/2010]
ISSUE: Defibtech, LLC, notified customers of a recall of 5,418 DBP-2800 Battery Packs used in the Lifeline AED and ReviveR AED (semi-automatic external defibrillators). 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.
BACKGROUND: This recall affects all DBP-2800 Battery Packs shipped prior to June 4, 2007. The DBP-2800 battery packs affected by this recall have been distributed globally to fire departments, EMS, health clubs, schools, and other organizations.
RECOMMENDATION: 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, and is available on the web at http://www.defibtech.com/batteryFA.
Read the complete MedWatch Safety Summary including a link to the firm press release at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm214916.htm
You are encouraged to report all serious adverse events and product quality problems to FDA MedWatch at www.fda.gov/medwatch/report.htm
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