FDA: Cardiac Science AED Corrective Action “Inadequate”

Cardiac Science Corp. reported in a filing with the U.S. Securities and Exchange Commission that the company has received a warning letter from the U.S. Food and Drug Administration saying the company is not following good manufacturing practices and that corrective action to its automatic external defibrillators is “inadequate.”

The Bothell, Wash., firm, which develops, manufactures and markets diagnostic and therapeutic products, said it has planned to issue a software update in February. However, the FDA said the move is intended to improve the products’ ability to detect the potential component problem, but is not designed to prevent component failure.

The letter also asserts other inadequacies, including the company’s procedures relating to the evaluation, investigation and follow up of complaints, procedures to verify the effectiveness of corrective and preventative actions and procedures relating to certain design requirements.

The company is investigating the issues identified by the FDA in the letter, it said, and will provide a written response.

“If we are unable to correct the inadequacies asserted in the FDA’s letter or otherwise satisfy the FDA’s concerns, we may be subject to regulatory action by the FDA, including seizure, injunction and/or civil monetary penalties. Any such actions could significantly disrupt our ongoing business and operations and have a material adverse impact on our financial position and operating results,” Cardiac Science said in the filing.