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Defibtech Gets 483 Noting Issues With AED Batteries

January 21, 2011
Defibtech has received a Form 483 after an FDA inspection uncovered issues with its automated external defibrillator (AED) batteries.

An inspection of the Guilford, Conn., company found a corrective measure was implemented to address high voltage during the charging of new battery packs. The corrective action report notes the device failed to shock due to an overshoot charge on the battery pack and an error code. But the company did not specify the error code in its data trend analysis, according to the form.

Additionally, Defibtech’s procedure for inspection, measuring and test equipment does not identify the process to identify, remove and evaluate equipment due for calibration.
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