FDA Issues Warning Against Faulty Defibrillators

A U.S. government agency on Tuesday warned that 280,000 external defibrillators may malfunction when used to assist people in sudden cardiac arrest and urged health care facilities to seek out alternative or replacement devices.

External defibrillators use an electric shock to restore a normal heartbeat to a patient in cardiac arrest.

The Food and Drug Administration (FDA) said the defective parts of 14 models of defibrillators made by Cardiac Science Corp. may not allow them to properly administer the shock needed to revive hearts that unexpectedly stop beating.

The FDA said in a statement that high-risk health care facilities including nursing homes should seek alternative devices if possible. If no substitutes are available, the FDA said it was possible to continue using the affected devices as they may be able to provide the necessary treatment.

Cardiac Science recalled two of its defibrillator models manufactured between August 2003 and August 2009 last November. The FDA found that additional models experienced similar problems.

Source Link: Newscore