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U.S. Department of Health and Human Services

Medical Devices

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External Defibrillators

External defibrillators are medical devices that diagnose life-threatening abnormal heart rhythms, or cardiac arrhythmia, and deliver electrical energy to the heart to restore its normal rhythm.  They are used in emergency situations on patients who have collapsed due to sudden cardiac arrest. When used in the first few minutes following collapse, these devices often save lives.

External defibrillators are used in many settings by medical professionals, emergency responders, and by trained and untrained bystanders.  The technology is based on decades of research and evolving knowledge.

There is risk associated with all medical devices, and external defibrillators can malfunction. The defibrillator industry has conducted dozens of recalls for external defibrillators, affecting hundreds of thousands of devices. Additionally, the FDA has received thousands of reports of external defibrillator malfunctions. While the FDA continues to advocate use of these important life-saving devices and is not recommending any change to current clinical practices, we believe the devices can be improved in ways that improve patient safety.

FDA is taking steps to foster the development of safer, more effective external defibrillators. (For more information, see the External Defibrillator Initiative Paper.)

On this website, you can learn more about external defibrillator problems, actions FDA is taking to improve safety and effectiveness, strategies to maintain external defibrillator readiness, and steps you can take to learn more about external defibrillators and reporting problems to FDA.

 

Contact FDA

1-800-638-2041
301-796-7100
Fax:301-847-8149
CDRH-Division of Industry and Consumer Education (DICE)(formerly DSMICA)

Office of Communication and Education

Center for Devices and Radiological Health

Food and Drug Administration

10903 New Hampshire Avenue

WO66-4621

Silver Spring, MD 20993
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