FDA Warns Cardiac Science About Defibrillator Actions

Cardiac Science Corp. (CSCX) said Thursday the Food & Drug Administration has warned it about how the company dealt with possible defibrillator malfunctions last year.

In November, the company announced a field correction on about 300,000 Powerheart and CardioVive defibrillators. At the time, the company said the devices "may not be able to deliver therapy during a resuscitation attempt." In a filing Thursday, the company said it is making a software update available this month for the affected devices.

The FDA said Cardiac Science wasn't in compliance with various manufacturing requirements because the move was intended to improve the products' ability to detect the potential problem but not prevent the actual failure. The agency also complained about Cardiac's procedures relating to the evaluation, investigation and follow up of complaints.

Earlier this month, the cardiac diagnostics company said it would recall about 12,200 defibrillators for the same problem.

Shares closed Wednesday at $2.87 and weren't active premarket. Its stock is down 37% the past year, but has climbed 29% so far in 2010.

-By Joan E. Solsman, Dow Jones Newswires; 212-416-2291; [e-mail]