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;
joan.solsman@dowjones.com