Automated External Defibrillators (AEDs) are critical life-saving devices that are used successfully thousands of times in the U.S. each year to treat patients experiencing sudden cardiac arrest. The FDA recognizes the important life-saving benefits of AEDs and that users trust they will operate properly. It is unlikely that an AED will malfunction, however, the FDA is aware of infrequent problems with AEDs that impact patient safety.
The following actions may help ensure that your device is ready when you need to use it.
- If you keep your AED in your home, make sure that you, your family, friends and visitors know where it is located and how to use it.
- Register your AED so the manufacturer can reach you with safety alerts and recall information.
- Check your AED manufacturer’s website periodically to find out about safety alerts or recalls, and to learn new information regarding your device.
- Sign up online for FDA medical device safety alerts.
Know how to operate your AED
- Use the training materials provided by the manufacturer and take refresher training periodically to maintain familiarity with your AED.
- Make sure you can read the AED’s displays and follow the Instructions for Use.
- Make sure you can hear the audio voice prompts and any alarms.
- Verify the AED is prepared for use at all times with all of its accessories (cables, pads, power cord, operator’s manual).
- Consider taking a nationally recognized training course in cardiopulmonary resuscitation (CPR) that includes the use of AEDs.
- File voluntary reports with the FDA for any problems you encounter with the AED.