AED PRO 90010202499991010Recalls & reported problems
Zoll Medical Corporation · Defibrillator ,ASSY, MAIN, SEMI AUTO W/MNL OVERRIDE, VOICE, AED PRO, ENGLISH · Class 3
All models of AED PRO (5)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 16
- Deaths reported
- 1
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00847946016135), received between Aug 23, 2017 and Jan 16, 2026 — classified as 1 death, 15 malfunctions.
The most frequently reported specific device problem is “Failure to Power Up” (5 reports).
1 FDA recall record name this device's identifier, 1 still open.
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 16, 2026.
Reports received per month
Recalls naming this device
- Jun 12, 2019Open, Classified
There is a potential for the device to fail to deliver energy to the patient.
Z-1931-2019 · Root cause: Device Design · Recall details · FDA record ↗
Most reported problems
Device problems
- Failure to Power Up5
- Failure of Device to Self-Test4
- Failure to Deliver Shock/Stimulation2
- Use of Device Problem2
- Battery Problem1
- Defibrillation/Stimulation Problem1
- Incorrect Interpretation of Signal1
- Unexpected Shutdown1
Patient problems
- No Patient Involvement7
- No Clinical Signs, Symptoms or Conditions6
- No Information2
- Necrosis1
Recent adverse event reports
The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 16, 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 24097133 ↗MalfunctionDec 23, 2022Failure to Deliver Shock/Stimulation; Battery Problem; Failure to Deliver Shock/Stimulation; Battery Problem
COMPLAINANT ALLEGED THAT WHILE PREPARING TO TREAT A PATIENT (AGE & GENDER UNKNOWN), THE DEVICE PROMPTED A "CHANGE BATTERY" MESSAGE. 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 16043063 ↗DeathJun 22, 2022Failure to Deliver Shock/Stimulation; Failure to Deliver Shock/Stimulation
COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO DEFIBRILLATE A PATIENT (AGE & GENDER UNKNOWN), THE DEVICE FAILED TO DISCHARGE. COMPLAINANT INDICATED THAT THE CLINICIAN OBTAINED ANOTHER DEVICE TO CONTINUE TREATING THE PATIENT. COMPLAINANT INDICATED THAT THE PATIENT SUBSEQUENTLY EXPIRED.
Patient problems: Necrosis
MAUDE report 14780299 ↗MalfunctionMay 13, 2022Unexpected Shutdown; Unexpected Shutdown
COMPLAINANT ALLEGED THAT DURING FUNCTIONAL TESTING, THE DEVICE SHUTS OFF AFTER PARTIAL BOOT CYCLE. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14399703 ↗MalfunctionAug 19, 2021Failure of Device to Self-Test; Failure 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 12344689 ↗MalfunctionAug 16, 2021Failure 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 12326123 ↗MalfunctionJun 30, 2021Failure 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 12093112 ↗MalfunctionOct 12, 2020Incorrect Interpretation of Signal; Incorrect Interpretation of Signal
COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO DEFIBRILLATE A (B)(6) MALE PATIENT IN CARDIAC ARREST, 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 DID NOT INDICATE THAT THERE WAS ANY ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION.
Patient problems: No Information
MAUDE report 10662803 ↗MalfunctionSep 15, 2020Use of Device Problem; Use of Device Problem
COMPLAINANT ALLEGED THAT DURING FUNCTIONAL TESTING, THE DEVICE DID NOT OPERATE CORRECTLY. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Patient Involvement
MAUDE report 10535245 ↗MalfunctionSep 15, 2020Use of Device Problem; Use of Device Problem
COMPLAINANT ALLEGED THAT DURING FUNCTIONAL TESTING, THE DEVICE DID NOT OPERATE CORRECTLY. NO FURTHER INFORMATION WAS AVAILABLE. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Patient Involvement
MAUDE report 10535124 ↗MalfunctionNov 11, 2019Failure 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 Patient Involvement
MAUDE report 9306031 ↗MalfunctionNov 26, 2018Failure to Power Up; Failure to Power Up
COMPLAINANT ALLEGED THAT DURING BIOMED TESTING, THE DEVICE FAILED SELF TEST. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Patient Involvement
MAUDE report 8102736 ↗MalfunctionNov 21, 2018Failure of Device to Self-Test; Failure of Device to Self-Test
COMPLAINANT ALLEGED THAT DURING FUNCTIONAL TESTING, THE DEVICE FAILED THE SELF TEST. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Patient Involvement
MAUDE report 8095722 ↗MalfunctionJul 23, 2018Defibrillation/Stimulation Problem; Defibrillation/Stimulation Problem
COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A PATIENT (AGE & GENDER UNKNOWN) THE DEVICE INAPPROPRIATELY DISPLAYED AN "ATTACH PADS" MESSAGE. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Information
MAUDE report 7711099 ↗MalfunctionJan 26, 2018Failure to Power Up; Failure to Power Up
COMPLAINANT ALLEGED THAT DURING FUNCTIONAL TESTING, THE DEVICE WOULD NOT POWER UP. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Patient Involvement
MAUDE report 7222461 ↗MalfunctionAug 23, 2017Failure of Device to Self-Test; Failure of Device to Self-Test
COMPLAINANT ALLEGED THAT DURING TESTING, THE DEVICE PROMPTED A "UNIT FAILED" MESSAGE. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Patient Involvement
MAUDE report 6814914 ↗
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- 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 · each recall links to the FDA recall notice
- 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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