FDA Cites Defibrillator Battery Maker for Quality Violations

A November 2018 FDA inspection has resulted in a warning letter for Zeller Power Products. The Wallace, ID-based company makes a replacement battery for Cardiac Science's PowerHeart Automated External Defibrillator (AED) G3. FDA said its inspection revealed that Zeller didn't have design validation documentation to justify the battery's five-year shelf life and an operational guarantee of up to four years after installation. The firm also failed to validate software used on the battery's printed circuit boards. A Zeller management representative provided the FDA investigator a product information sheet for the battery and said that statistics were most likely taken from the specifications of the OEM battery by Cardiac Science. The agency's investigators explained that the batteries produced by Zeller are not Cardiac Science products and the Zeller design and specifications must be validated. The software installed on the printed circuit boards included in each battery also has not been validated, according to the warning letter. The software is written to make the battery compatible with the Cardiac Science defibrillator and is programmed during production to tell the device the battery has not been used and is ready for use, FDA noted. "The device has not been validated to determine that it conforms to OEM specifications or defined user needs and intended uses," the agency said in its letter to Zeller. "Furthermore, your response indicated...
Source: MDDI - Category: Medical Devices Authors: Tags: Regulatory and Compliance Source Type: news