FDA Warns ZOLL Medical Corporation about Battery Life for Defibrillators
Published: Jul 13, 2011
The FDA says Zoll medical failed to demonstrate that they properly validate battery life for their automated external defibrillators after more than a dozen complaints. 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."