ZOLL Takes Corrective Action on Defibrillators

ZOLL Medical Corp., a manufacturer of resuscitation devices and related software, has taken corrective action on its Zoll AED Plus automated external defibrillators after discovering that batteries do not work properly with some defibrillators manufactured before Feb. 12. In addition, the AED Plus self-test software installed in these devices does not correctly detect defective batteries. One person has died as a result, according to company officials.

Consequently, the defibrillator may fail to deliver defibrillation shocks when treating sudden cardiac arrest.

A software update that can be downloaded and installed from the company’s Web site successfully fixes the computer glitch. The new software, included in current shipments of the AED Plus, can detect a battery defect condition and remind the user to install fresh batteries, as long as it occurs within the maximum five-year standby lifetime.

Chelmsford, Mass.-based ZOLL began notifying customers with affected devices on Feb. 12. The company advised customers to replace batteries on a three-year schedule until their device software can be updated. The corrective action applies to about 180,000 units.

ZOLL has reviewed all reported patient events and found up to three additional cases in which a shock was not delivered to a patient and the battery may have experienced the identified problem. Company officials said that in one case the patient subsequently died.

For instructions on downloading the software and ordering replacement batteries, go to www.zollaedplusbatteryhelp. com/. Customers can also call ZOLL technical support at (800) 348-9011 or email [email protected].