AED 3 1128-001103-01Recalls & 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
Quick summary
This Zoll AED 3 automated external defibrillator has 105 reports, including 2 deaths and 2 injuries. Many reports describe the device failing to power up or failing its self-test, and some describe unexpected shutdowns, flickering displays, or error codes, with a report noting the device shut down while a patient was being treated. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 108
- Deaths reported
- 2
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 108 adverse event reports that list this exact device (DI 00847946020071), received between Jun 18, 2019 and Sep 21, 2026 — classified as 2 deaths, 2 injuries, 104 malfunctions.
The most frequently reported specific device problem is “Failure to Power Up” (44 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 Up44
- Failure of Device to Self-Test19
- Unexpected Shutdown11
- Incorrect Interpretation of Signal8
- Unable to Obtain Readings7
- Reset Problem5
- Erratic or Intermittent Display3
- Failure to Cycle3
Patient problems
- No Clinical Signs, Symptoms or Conditions79
- Insufficient Information16
- No Patient Involvement8
- No Information2
- Cardiac Arrest1
- Necrosis1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 25 most recent of 108 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 21, 2026Incorrect Interpretation of Signal
COMPLAINANT ALLEGED THAT WHILE ANALYZING THE HEART RHYTHM OF A PATIENT (AGE & GENDER UNKNOWN), THE DEVICE ISSUED A "SHOCK ADVISED" PROMPT FOR A HEART RHYTHM THEY BELIEVED WAS NON-SHOCKABLE. COMPLAINANT INDICATED THAT THERE WAS NO ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50841321 ↗MalfunctionSep 15, 2026Failure 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 50775572 ↗MalfunctionSep 10, 2026Failure to Power Up
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50714352 ↗MalfunctionAug 3, 2026Failure to Power Up
COMPLAINANT ALLEGED THAT DURING INCOMING INSPECTION, THE DEVICE WOULD NOT POWER UP. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50114540 ↗MalfunctionJul 27, 2026No Display/Image; Failure of Device to Self-Test
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50036474 ↗MalfunctionJul 17, 2026Failure 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 25855209 ↗MalfunctionJul 1, 2026Failure to Cycle
COMPLAINANT ALLEGED THAT DURING FUNCTIONAL TESTING, THE DEVICE HALTS AFTER PARTIAL BOOT CYCLE. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25677386 ↗MalfunctionJun 19, 2026Failure to Cycle; Power Conditioning Problem; Use of Device Problem
COMPLAINANT ALLEGED THAT DURING FUNCTIONAL TESTING, A CRITICAL ERROR 11 WAS OBSERVED IN THE ERROR LOG. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25563923 ↗MalfunctionApr 3, 2026Failure 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 24778252 ↗MalfunctionMar 20, 2026No Display/Image; Failure to Power Up
COMPLAINANT ALLEGED THAT DURING FUNCTIONAL TESTING, THE DEVICE'S DISPLAY FLICKERS. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24649327 ↗MalfunctionMar 19, 2026Unexpected Shutdown
COMPLAINANT ALLEGED WHILE ATTEMPTING TO TREAT A FEMALE PATIENT (AGE UNKNOWN), THE DEVICE INAPPROPRIATELY SHUT DOWN. COMPLAINANT INDICATED THAT THERE WAS NO ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24640145 ↗MalfunctionFeb 24, 2026Failure of Device to Self-Test
COMPLAINANT ALLEGED THAT DURING FUNCTIONAL TESTING, THE DEVICE PROMPTED A "UNIT FAILED" MESSAGE. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24430407 ↗MalfunctionFeb 24, 2026Failure 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 24428958 ↗MalfunctionFeb 13, 2026Failure 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 24338117 ↗MalfunctionFeb 10, 2026Failure 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 24304720 ↗MalfunctionDec 19, 2025Erratic or Intermittent Display; Erratic or Intermittent Display
COMPLAINANT ALLEGED THAT DURING FUNCTIONAL TESTING, THE DEVICE'S DISPLAY FLICKERED. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23853713 ↗MalfunctionNov 17, 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 23571145 ↗MalfunctionNov 10, 2025Erratic or Intermittent Display; Erratic or Intermittent Display
COMPLAINANT ALLEGED THAT DURING FUNCTIONAL TESTING, THE DEVICE'S DISPLAY FLICKERED. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23509055 ↗MalfunctionNov 7, 2025Erratic or Intermittent Display; Erratic or Intermittent Display
COMPLAINANT ALLEGED THAT DURING FUNCTIONAL TESTING, THE DEVICE'S SCREEN WAS FLASHING. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23496748 ↗MalfunctionOct 16, 2025Failure of Device to Self-Test; Failure of Device to Self-Test
COMPLAINANT ALLEGED THAT DURING INCOMING INSPECTION, THE DEVICE PROMPTED A "UNIT FAILED" MESSAGE. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23316533 ↗MalfunctionOct 9, 2025Incorrect Interpretation of Signal; Incorrect Interpretation of Signal
COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A PATIENT (AGE & GENDER UNKNOWN) THE DEVICE GAVE A "NO SHOCK ADVISED" PROMPT FOR A RHYTHM CLINICIANS BELIEVED WAS SHOCKABLE. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION.
Patient problems: Insufficient Information
MAUDE report 23257992 ↗MalfunctionSep 12, 2025Failure to Power Up; Failure to Power Up
COMPLAINANT ALLEGED THAT DURING FUNCTIONAL TESTING, THE DEVICE WOULD INTERMITTENTLY 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 23041473 ↗DeathAug 20, 2025Unexpected Shutdown; Unexpected Shutdown
COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO DEFIBRILLATE A PATIENT (AGE & GENDER UNKNOWN), THE DEVICE INAPPROPRIATELY SHUTDOWN. COMPLAINANT INDICATED THAT THE CLINICIAN OBTAINED ANOTHER DEVICE TO CONTINUE TREATING THE PATIENT. COMPLAINANT INDICATED THAT THE PATIENT SUBSEQUENTLY EXPIRED.
Patient problems: Insufficient Information
MAUDE report 22852233 ↗MalfunctionAug 6, 2025Failure to Power Up; Failure to Power Up
COMPLAINANT ALLEGED THAT DURING TRAINING BY FACILITY STAFF, 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 22726273 ↗MalfunctionJun 20, 2025Inappropriate/Inadequate Shock/Stimulation; Inappropriate/Inadequate Shock/Stimulation
COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO DEFIBRILLATE AN 86-YEAR-OLD MALE PATIENT, THE DEVICE GAVE A "NO SHOCK ADVISED" PROMPT FOR A RHYTHM CLINICIANS BELIEVED WAS SHOCKABLE. COMPLAINANT INDICATED THAT THE CLINICIAN OBTAINED ANOTHER DEVICE TO CONTINUE TREATING THE PATIENT. COMPLAINANT INDICATED THAT THE PATIENT SUBSEQUENTLY EXPIRED.
Patient problems: Insufficient Information
MAUDE report 22297176 ↗
Other Automated external defibrillators (non-wearable) devices
- NA 861290Philips Medical Systems Hsg · Automated External Defibrillators (Non-Wearable)12 deaths5,167 reports
- NA 861288Philips Medical Systems Hsg · Automated External Defibrillators (Non-Wearable)21 deaths5,015 reports
- NA 861289Philips Medical Systems Hsg · Automated External Defibrillators (Non-Wearable)7 deaths3,385 reports
- R SERIES 30001005201310012Zoll Medical Corporation · Automated external defibrillators (non-wearable)10 deaths1,720 reports
- PHILIPS HeartStart FRxPhilips Electronics North America Corporation · Automated external defibrillators (non-wearable)26 deaths1,586 reports
- LIFEPAK CR2 99512Physio-Control, Inc. · Automated external defibrillators (non-wearable)8 deaths1,502 reports
- Lifeline Configuration DDU-100ADefibtech, L.L.C. · Automated External Defibrillators (Non-Wearable)1 death1,285 reports
- 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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