AED 3Recalls & reported problems across all models
Zoll Medical Corporation · 7 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 465
- Deaths reported
- 6
- Injuries reported
- 5
- Recalls
- 0
We found 7 models of AED 3 by Zoll Medical Corporation in the FDA's device registry (GUDID). Together they are named in 465 adverse event reports in the FDA's MAUDE database, received between Jun 18, 2019 and Sep 29, 2026 — classified as 6 deaths, 5 injuries, 454 malfunctions.
The most frequently reported specific device problem is “Failure to Power Up” (230 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported AED 3 problems
Device problems
- Failure to Power Up230
- Failure of Device to Self-Test114
- No Display/Image25
- Unexpected Shutdown24
- Unable to Obtain Readings23
- Erratic or Intermittent Display18
- Incorrect Interpretation of Signal13
- Reset Problem11
Patient problems
- No Clinical Signs, Symptoms or Conditions415
- Insufficient Information31
- No Patient Involvement10
- Cardiac Arrest2
- No Information2
- Administration Site Reaction1
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Decreased Respiratory Rate1
AED 3 models
7 models, most reported first. Each model has its own page with its reports, recalls and device details.
- AED 3 1128-001102-01Automated external defibrillators (non-wearable)1 death262 reports
- AED 3 1128-001103-01Automated external defibrillators (non-wearable)2 deaths108 reports
- AED 3 1128-001101-01Automated external defibrillators (non-wearable)3 deaths79 reports
- AED 3 1128-001103-01-66Automated external defibrillators (non-wearable)8 reports
- AED 3 1028-000001Automated external defibrillators (non-wearable)5 reports
- AED 3 1128-001102-01-66Automated external defibrillators (non-wearable)2 reports
- AED 3 1128-001101-01-66Automated external defibrillators (non-wearable)1 report
Recent AED 3 adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026Failure of Device to Self-Test
COMPLAINANT ALLEGED THAT DURING FUNCTIONAL TESTING, THE DEVICE PROMPTED A "UNIT FAILED" MESSAGE. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50934116 ↗MalfunctionSep 29, 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 50933230 ↗MalfunctionSep 28, 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 50915030 ↗MalfunctionSep 24, 2026Failure 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 50883012 ↗InjurySep 24, 2026Self-Activation or Keying
COMPLAINANT ALLEGED WHILE ATTEMPTING TO TREAT A PATIENT (AGE & GENDER UNKNOWN), THE DEVICE SELF-DISCHARGED. IT IS UNKNOWN WHETHER THE EVENT RESULTED IN HARM TO THE PATIENT OR CLINICAL STAFF.
Patient problems: Insufficient Information
MAUDE report 50882106 ↗DeathSep 22, 2026Unexpected Shutdown
COMPLAINANT ALLEGED WHILE ATTEMPTING TO TREAT A (b)(6) YEAR-OLD MALE PATIENT, THE DEVICE INAPPROPRIATELY SHUT DOWN.COMPLAINANT INDICATED THAT THE PATIENT SUBSEQUENTLY EXPIRED.
Patient problems: Insufficient Information
MAUDE report 50853789 ↗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 18, 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 50818140 ↗MalfunctionSep 18, 2026Failure to Cycle
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 50817036 ↗MalfunctionSep 17, 2026No Display/Image
COMPLAINANT ALLEGED THAT DURING FUNCTIONAL TESTING, THE DEVICE'S SCREEN TURNED COMPLETELY WHITE AND WAS ILLEGIBLE.COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50804352 ↗MalfunctionSep 16, 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 50786789 ↗MalfunctionSep 15, 2026Unable to Obtain Readings
COMPLAINANT ALLEGED THAT DURING INCOMING INSPECTION, THE DEVICE DISPLAYED A "CHECK PADS" MESSAGE. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50775823 ↗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 11, 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 50730662 ↗MalfunctionSep 10, 2026Failure to Power Up
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50714352 ↗
Other Zoll Medical Corporation products
- R SERIES94 models · 8,522 reports
- X SERIES163 models · 6,915 reports
- AED PLUS30 models · 1,966 reports · 1 recall
- Z Vent6 models · 1,204 reports · 1 recall
- Model EMV+ Vent, Army, MRI3 models · 964 reports
- E SERIES160 models · 833 reports
- ONESTEP8 models · 586 reports
- M SERIES BIPHASIC59 models · 572 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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