ZOLL Medical Corporation has initiated a voluntary worldwide field corrective action on its ZOLL AED Plus automated external defibrillator, affecting about 180,000 units.
The company has determined that some batteries do not work properly when used with AED Plus defibrillators manufactured prior to Feb. 12, 2009 with serial numbers below X_ _ _200000.
In addition, Zoll said said the version of the AED Plus self-test software installed in the affected devices does not adequately detect defective batteries. The company said the problem can be corrected with a software update.
As a result of the two issues, the AED Plus defibrillator may fail to deliver defibrillation shocks during treatment of sudden cardiac arrest, according to the company, which said its investigation was continuing.
While the corrective action applies to approximately 180,000 units, Zoll said devices installed for at least three years are at the highest risk, which encompasses about 80,000 units.
Although the issue was identified through customer reports from non-clinical testing, the company said there was one clinical event reported in which a defibrillation shock was not delivered and the patient subsequently died. An evaluation of the device found that the batteries experienced the identified problem.
The required correction is available in the form of a software update, which can be downloaded from the company’s Web site and installed by users.
Working with its distributors, ZOLL began notifying customers with affected devices on Feb. 12, recommending immediate replacement of batteries on a three-year schedule until the software is updated. The company said there is no need to remove devices from service pending the corrective action.
More information on the corrective action, including instructions for downloading software and ordering replacement batteries is available at http://www.zollaedplusbatteryhelp.com/. Customers can also call ZOLL Technical Support at 800-348-9011 or email Tservice_AED@zoll.com.