FDA Warns On GE, Cardiac Sciences External Heart Defibrillators
April 27 2010 - 2:16PM
Dow Jones News
The Food and Drug Administration warned of additional problems
with external heart defibrillators made by Cardiac Science Corp.
(CSCX) and GE Healthcare (GE).
Such external defibrillators are used worldwide in health care
facilities, public places or in the home. However, the FDA said 14
models of defibrillators may malfunction during attempts to rescue
people in sudden cardiac arrest, a condition in which the heart
stops beating.
The FDA said faulty components in some of Cardiac Science
Corp.'s defibrillators may cause the devices to fail to properly
deliver a shock. Other problems include interruption of
electrocardiography analysis, failure to recognize electrode pads,
and interference or background noise that makes the device unable
to accurately analyze heart rhythm, the FDA said.
Two models of Cardiac Sciences devices--the Powerheart and
CardioVive --were recalled last November. The recall affected
devices manufactured between August 2003 and August 2009.
However, the FDA said two additional Cardiac Science models,
marketed under the Nihon Kohden name, and two GE Responder models
have similar problems.
The agency said Cardiac Science Corp. has issued a software
update for two of its Powerheart defibrillators and plans to issue
similar software updates for other affected devices.
But, the FDA said it reviewed the software update and found that
it "detects some, but not all, identified defects."
Representatives from GE Healthcare and Cardiac Science weren't
immediately available for comment.
-By Jennifer Corbett Dooren, Dow Jones Newswires; 202-862-9294;
jennifer.corbett@dowjones.com
Cardiac Science Corp (MM) (NASDAQ:CSCX)
Historical Stock Chart
From Mar 2024 to Apr 2024
Cardiac Science Corp (MM) (NASDAQ:CSCX)
Historical Stock Chart
From Apr 2023 to Apr 2024