We have received reports that following a long period (typically greater than four years) without use, a ZOLL® AED Plus® may prompt “change batteries” during use and fail to deliver therapy. Turning the device off completely, waiting ten seconds for the unit to re-set and then turning it back on is necessary to resume proper operation. Our investigation of this problem has determined that some batteries may develop high internal resistance that interferes with the batteries expected performance, lengthening charging time beyond specified and clinically acceptable limits.
ZOLL Medical Corporation is informing owners of all AED Plus devices with serial numbers below X_ _ _200000 to replace batteries that have been installed in devices for a period longer than three (3) years and at subsequent three (3) year intervals.
Required Corrective Actions
(1) Determine the date batteries were installed in your device.
(2) If batteries were installed more than three (3) years ago, replace the batteries as soon as possible and add the enclosed label showing the next scheduled replacement date. Read and add the enclosed addendum incorporating this information to the administrator’s guide.
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(3)If batteries are not more than three (3) years old, add the enclosed label completed with the next scheduled replacement date. Read and add the enclosed addendum incorporating this information to the administrator’s guide.
Units above serial number X_ _ _200000 are not affected by this corrective action as they contain software that can detect this battery condition and identify when batteries require replacement. In lieu of adding the battery replacement label users may obtain this new software for their AEDs at no cost at www.ZOLLAEDPlusbatteryhelp.com
