United States -
The U.S. Food and Drug Administration issued a warning Tuesday
that some external defibrillators used worldwide might
malfunction. The FDA said about 280,000 external
defibrillators manufactured by the Cardiac Science Corp. and
used in health care facilities, public places or in homes may
contain faulty components that can cause the devices to
malfunction.
The FDA said malfunctions might occur during attempts to
rescue people in sudden cardiac arrest -- a condition in which
the heart suddenly stops beating. External defibrillators are
used to send an electric shock to the heart to restore normal
heart rhythm.
"In addition to failure to deliver needed shocks, other
problems with the affected models may 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.
The affected 14 models, which include automated and
semi-automated devices, are:
-- Powerheart models 9300A, 9300C, 9300D, 9300E, 9300P, 9390A
and 9390E.
-- CardioVive models 92531, 92532 and 92533.
-- Nihon Kohden models 9200G and 9231.
-- GE Responder models 2019198 and 2023440.
The FDA recommends obtaining alternative external
defibrillators and arranging for the repair or replacement of
the affected defibrillators.
If no alternative external defibrillators are available, the
FDA recommends continuing to use the affected devices if
needed, because they may still deliver necessary therapy.
Written by United Press International