The U.S. Food & Drug Administrations filed a warnings against ZOLL Medical Corporation (NSDQ:ZOLL) for allegedly failing to validate battery life cycles for its external defibrillators.
Zoll has logged 15 complaints between September 2009 and January 2011 alleging that the batteries in the Chelmsford, Mass.-based company’s automated external defibrillators died prior to their 5-year expectations, the agency said in its letter.
The letter acknowledged several responses to the FDA’s complaints against the company’s methods for battery life calculations, which the agency says fail to account for the build up of a “high resistive layer," also called passivation. The letter finds Zoll’s responses "inadequate."
"Your firm submitted the "AED Battery Life Calculation" memo dated November 5, 2009 as Att. 2 in your FDA 483 response in support of the calculation used to determine battery life cycle," the letter reads. "This response is inadequate because the memo does not provide the formula used in the calculation, reference the location of data which supports the calculation, or identify test methods or equipment used to obtain data. The memo also fails to address the impact of passivation on battery life or identify if it is considered in the calculation."
"We acknowledge your statement that your firm has "implemented a plan that simulates and monitors the battery performance within our product over the course of 5 years". However your firm already identified this corrective action as part of CAPA 2009-026 and failed to implement it in 2009," the FDA added.
"We believe we need to provide additional data and action plans concerning battery life to satisfy the FDA on this matter," Zoll officials said in the filing. "We have always complied with warning letters we have received in the past, and we intend to address this warning letter to the full satisfaction of the FDA."
Zoll’s stock was down 1.92 percent to $56.78 in mid-day trading today.