FDA Recall: Battery packs used in AED’s recalled over detection errors
06/10/2010 // WPB, FL, USA // Nicole Howley // Nicole Howley
Guilford, CT—A voluntarily recall has been initiated by Defibtech, LLC of 5,418 DBP-2800 Battery Packs used in the Lifeline AED® and ReviveR AEDTM (semi-automatic external defibrillators). The U.S. Food and Drug Administration (FDA) released the recall on June 3, 2010.
The recall involves all DBP- 2800 Battery Packs shipped prior to June 4, 2007.
The FDA reported, “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 determined the need for this recall after learning of four reports from end users of this malfunction during patient use.”
Defibtech will be mailing recommendations for the end consumer to follow until the battery pack has been corrected, allowing the battery pack to remain operational. All affected customers will be notified.
The customer notification, and instructions on determining whether a battery pack is affected, can be found on the www.defibtech.com/batteryFA1 web page. For further information about this recall, please visit to the above referenced web page, contact your distributor, or contact Defibtech at [email protected], 1-877-453-4507 or 1- 203-453-4507.
The recalled battery packs were distributed globally to fire departments, EMS, health clubs, schools, and other organizations. The affected battery packs are used in AEDs, which can be identified by the words “Lifeline AED®” and “ReviveR AEDTM” on the front of the device.
The FDA stated, “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.”
Any adverse reactions experienced with the use of this product and/or quality problems should also be reported to the FDA’s MedWatch Program by phone at 1-800- FDA-1088, or on the MedWatch Web site at www.fda.gov/medwatch.
Legal News Reporter: Nicole Howley-Legal news for product liability attorneys.