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Medical Devices

Reporting Problems with External Defibrillators

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.

User Facilities:

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:

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
    • Oxygenation
    • 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

Page Last Updated: 06/10/2015
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