FDA Warns of Faulty Parts in 14 Defibrillator Models
Agency recommends that those with affected models find alternatives
WEDNESDAY, April 28 (HealthDay News) -- The U.S. Food and Drug Administration has issued a warning about external defibrillators manufactured by Cardiac Science Corp. that may malfunction when being used to rescue people in cardiac arrest.
About 280,000 defibrillators, used internationally in homes, public settings and health care facilities, have faulty components that may result in the devices failing to properly deliver the shock needed to restore normal heart rhythm in the event of sudden cardiac arrest, according to the FDA. The affected models may also have problems with interruption of electrocardiography analysis, failure to recognize electrode pads, and interference that makes the device unable to analyze heart rhythm accurately.
The 14 affected models are the Powerheart models 9300A, 9300C, 9300D, 9300E, 9300P, 9390A and 9390E; the CardioVive models 92531, 92532 and 92533; the Nihon Kohden models 9200G and 9231; and the GE Responder models 2019198 and 2023440. The FDA recommends that those with faulty models obtain alternative defibrillators and arrange for replacement or repair of the affected models.
"The FDA is issuing this notice so that users can take the proper steps necessary to assure they have access to safe and effective defibrillators," Jeffrey Shuren, M.D., director of the FDA's Center for Devices and Radiological Health, said in a statement.