AED 3 1128-001103-01-66Recalls & reported problems
Zoll Medical Corporation · BLS ZOLL AED 3,ENGLISH,AHA · Class 3
All models of AED 3 (7)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 8
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00847946026363), received between Mar 15, 2023 and Jul 28, 2026 — classified as 1 injury, 7 malfunctions.
The most frequently reported specific device problem is “Failure to Power Up” (5 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Failure to Power Up5
- Energy Output Problem1
- Incorrect Interpretation of Signal1
- Unexpected Shutdown1
- Unintended Electrical Shock1
Patient problems
- No Clinical Signs, Symptoms or Conditions7
- Insufficient Information1
Recent adverse event reports
The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 28, 2026Incorrect Interpretation of Signal
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50055059 ↗MalfunctionDec 19, 2025Unexpected Shutdown; Unexpected Shutdown
COMPLAINANT ALLEGED THAT DURING FUNCTIONAL TESTING, THE DEVICE INAPPROPRIATELY SHUT DOWN. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23849850 ↗MalfunctionMay 21, 2025Failure to Power Up; Failure to Power Up
COMPLAINANT ALLEGED THAT DURING FUNCTIONAL TESTING, THE DEVICE WOULD NOT POWER UP. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22063153 ↗MalfunctionOct 1, 2024Failure to Power Up; Failure to Power Up
COMPLAINANT ALLEGED THAT DURING FUNCTIONAL TESTING, THE DEVICE WOULD NOT POWER UP. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20346927 ↗MalfunctionFeb 28, 2024Failure to Power Up; Failure to Power Up
COMPLAINANT ALLEGED THAT DURING FUNCTIONAL TESTING, THE DEVICE WOULD NOT POWER UP. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18796056 ↗MalfunctionJul 10, 2023Failure to Power Up; Failure to Power Up
COMPLAINANT ALLEGED THAT DURING FUNCTIONAL TESTING, THE DEVICE WOULD NOT POWER UP. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17292482 ↗InjuryMay 3, 2023Energy Output Problem; Unintended Electrical Shock; Energy Output Problem; Unintended Electrical Shock
COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO MONITOR A MALE PATIENT (AGE UNKNOWN), UPON REMOVAL OF THE ELECTRODE PADS FROM HIS CHEST, THE MALE PATIENT RECEIVED AN UNINTENDED DELIVERY OF ENERGY. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION.
Patient problems: Insufficient Information
MAUDE report 16860838 ↗MalfunctionMar 15, 2023Failure to Power Up; Failure to Power Up
COMPLAINANT ALLEGED THAT DURING FUNCTIONAL TESTING, THE DEVICE WOULD NOT POWER UP. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16547547 ↗
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- PHILIPS HeartStart FR3Philips Electronics North America Corporation · Automated External Defibrillators (Non-Wearable)10 deaths1,188 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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