ZOLL Conducting 'Corrective Action' on 180,000 AEDs
ZOLL Medical Corporation on April 2 announced a voluntary worldwide "field corrective action" affecting about 180,000 ZOLL AED Plus® automated external defibrillators. The AED Plus® is equipped with Real CPR Help®, which provides feedback on compressions to rescuers.
In a news release, the Chelmsford, Mass.-based company said it "has determined that some batteries do not work properly when used with AED Plus defibrillators manufactured prior to February 12, 2009 (serial numbers below X_ _ _200000). In addition, the version of the AED Plus self-test software installed in these devices does not adequately detect defective batteries. As a result of these two issues, the AED Plus defibrillator may fail to deliver defibrillation shocks during treatment of sudden cardiac arrest." ZOLL said its investigation of the problem has not been completed, but it found one reported battery failure in the AED Plus took place in a rescue where the victim died, and the company's review of all reported patient events found up to three additional cases of possible failure, including one fatality.
About 80,000 units that have been installed for at least three years are at the highest risk, ZOLL said, adding that the problem was identified through customer reports from non-clinical testing.
The correction to be made is a software update that can be downloaded from the company's Web site and installed by the user. It is included in current shipments of the AED Plus and can detect the battery defect condition if it occurs within the maximum five-year standby lifetime and alert the user to install fresh batteries. Further information on this corrective action, including instructions for downloading software and ordering replacement batteries, is available at www.zollaedplusbatteryhelp.com, or call 800-348-9011 or e-mail [email protected].
ZOLL said it appears high internal resistance can develop in some batteries after several years in standby mode, adding, "It is possible that this can lengthen charging time beyond specified and clinically acceptable limits, resulting in the failure of the AED Plus to deliver a defibrillation shock. It is difficult to predict which batteries may develop this condition, and the affected devices’ self-test does not detect this condition. The FDA has been notified of this problem and is expected to classify it as a recall." The action does not apply to AED Plus devices manufactured after February 12, 2009 (serial numbers above X_ _ _200000), and the company does not expect a disruption in AED Plus supply or unusual backlog from this corrective action.
ZOLL had released a customer notification letter dated Feb. 12, 2009, that informed AED Plus owners about the battery problem and announced the help Web site would become available Feb. 16.