Prompt reporting of adverse events can help the FDA identify and better understand the risks associated with medical devices.
If you suspect a problem with an external defibrillator, we encourage you to file a report with the FDA.
Health Care Professionals and Consumers:
We encourage you to file a voluntary report through MedWatch, the FDA Safety Information and Adverse Event Reporting program.
Health care personnel employed by facilities that are subject to FDA's user facility reporting requirements should follow the reporting procedures established by their facilities.
Device manufacturers must comply with the Medical Device Reporting (MDR) regulations.
What to Include in a Report:
To help us learn as much as possible about the adverse events or problems associated with external defibrillators, please include the following information, if available, in your reports:
- Details surrounding the event including, but not limited to:
- Make and model of external defibrillator
- Energy level used and whether shock was or was not delivered
- Waveform (biphasic truncated exponential, biphasic rectilinear or monophasic), if known
- Cardiac rhythms noted
- Drug therapy
- Paddles or pads used
- Any delay in therapy
- Outcome of resuscitation, including any adverse outcomes related to the device
- Whether or not the external defibrillator has been evaluated, including the evaluation results, if available.
- Any additional identifying information, including catalog number and serial number.
If You Have Questions about the Medical Device Reporting (MDR) Regulation, Including Interpretation of MDR Policy:
- Email: RSMB@fda.hhs.gov
- Call: (301) 796-6670 (voice)
- Or write to: Food and Drug Administration
Center for Devices and Radiological Health
Reporting Systems Monitoring Branch
10903 New Hampshire Avenue
WO Bldg. 66, Room 3217
Silver Spring, MD 20993-0002