Zoll Medical Corp. has received an FDA warning letter for allegedly failing to validate the battery life of its automated external defibrillators, according to the warning letter.
The warning letter said Zoll received 15 complaints from Sept. 2009-Jan. 2011 on battery depletion before the calculated five-year battery life cycle was completed. It added that the company developed a life-cycle test plan but failed to implement it.
Following inspections of a company site in Massachusetts, the agency determined that Zoll's initial battery life cycle validation didn't account for build-up of a high resistive layer, known as passivation.
Read the FDA warning letter on defibrillators.
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