Cardiac Science Automated External Defibrillators are Faulty, FDA Warns
About 300,000 Powerheart and CardioVive automated external defibrillators (AEDs) made by Cardiac Science Corp. may be defective and fail to deliver life-saving electrical shocks to the heart when needed, the Food and Drug Administration is warning.
Also, the self-test mode on the devices may fail to detect the defective condition before they are used on patients, according to a recently issued FDA initial communication. The devices are used for emergency treatment of victims suffering from sudden cardiac arrest who are unresponsive and not breathing.
The manufacturer has received “multiple complaints” about the defective AEDs, but officials did not say how many complaints have been received. The G3 Series devices involved in the warning were manufactured between August 2003 and August 2003 and distributed worldwide, officials said.
Two Cardiac Science Models Involved in Warning
The following Cardiac Science AED models are included in the warning:
• Powerheart models: 9300A, 9300C, 9300D, 9300E, 9300P, 9390A, 9390E
• CardioVive: 92531, 92532, and 9253
Use Other AEDs, If Available
The display screen on the AEDs may not tell the user that the device is not working properly, so patients are at risk of suffering life-threatening complications from their use, the FDA said. Officials are cautioning healthcare professionals to use alternate AED devices when they are available until the Powerheart and CardioVive models can be repaired or replaced.
If an alternate AED is not available, the FDA recommends using the Powerheart and CardioVive AEDs if needed, as the units may still be able to deliver the necessary therapy.
“The consequences of not attempting to defibrillate a patient outweigh the risk that these devices may fail,” the FDA said.
Related posts:
- FDA Warns of Faulty Manufacturing at Abbott Eye-Device Plant The Food and Drug Administration has warned a subsidiary of...
- FDA Warns of Problems With External Biphasic Defibrillators The Food and Drug Administration is warning medical professionals about...
- Philips HeartStart Defibrillators Recalled Due to Faulty Memory Chips About 5,400 HeartStart FR2+ automated external defibrillators made by Philips...
- Some LIFEPAK CR Defibrillators Recalled Physio-Control, Inc. and the Food and Drug Administration today are...
- Medtronic Warns About Faulty Batteries in Implanted Heart Devices Medtronic Inc., a worldwide leader in heart defibrillators, pacemakers, and...
Please note that the dates of manufactured faulty devices is from August 2003-August 2009