R SERIES 30001000301110012Recalls & reported problems
Zoll Medical Corporation · Defibrillator ,R SERIES, MAIN, ALS, 3/5 LD, AC PWR, STD ECG, PACE, ETCO2, CF/USB, DMST · Class 3
Quick summary
This Zoll R Series defibrillator is an automated external defibrillator. Many of its 975 reports describe the unit failing to power up, failing to deliver a shock, showing no display, or shutting down, and most do not describe any effect on the patient. The reports mention 10 deaths and 6 injuries. 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
- 979
- Deaths reported
- 10
- Injuries reported
- 7
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 979 adverse event reports that list this exact device (DI 00847946017200), received between Aug 13, 2015 and Sep 24, 2026 — classified as 10 deaths, 7 injuries, 962 malfunctions.
The most frequently reported specific device problem is “Defibrillation/Stimulation Problem” (201 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Defibrillation/Stimulation Problem201
- No Display/Image195
- Unable to Obtain Readings187
- Failure to Power Up118
- Failure of Device to Self-Test60
- Pacing Problem60
- Failure to Deliver Shock/Stimulation57
- Grounding Malfunction26
Patient problems
- No Clinical Signs, Symptoms or Conditions700
- No Patient Involvement177
- Insufficient Information43
- No Consequences Or Impact To Patient19
- No Information18
- Burn(s)6
- Death4
- Intraoperative Cardiac Valve Injury2
Recent adverse event reports
The 25 most recent of 979 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 24, 2026Unable to Obtain Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50889312 ↗MalfunctionSep 24, 2026Defibrillation/Stimulation Problem
COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A PATIENT (AGE & GENDER UNKNOWN), THE DEVICE DISPLAYED "DEFIB FAULT 76" 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 50882978 ↗InjurySep 21, 2026Unintended Electrical Shock
COMPLAINANT ALLEGED WHILE ATTEMPTING TO DEFIBRILLATE A PATIENT A 27-YEAR-OLD FEMALE NURSE RECEIVED AN UNINTENDED DELIVERY OF ENERGY.COMPLAINANT INDICATED THAT THE CLINICIAN WAS ADMITTED TO HOSPITAL FOR MONITORING DUE TO THE REPORTED MALFUNCTION.
Patient problems: Electric Shock
MAUDE report 50839100 ↗MalfunctionSep 15, 2026Unable to Obtain Readings
COMPLAINANT ALLEGED THAT DURING A ROUTINE SHIFT CHECK BY A CLINICIAN, THE DEVICE DISPLAYED AN "ERROR FFFF" MESSAGE. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50775707 ↗MalfunctionSep 15, 2026Failure of Device to Self-Test
COMPLAINANT ALLEGED THAT DURING A ROUTINE SHIFT CHECK BY A CLINICIAN, THE DEVICE FAILED SELF TEST.COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50772589 ↗MalfunctionSep 2, 2026Unable to Obtain Readings
COMPLAINANT ALLEGED THAT DURING BIOMED TESTING, THE DEVICE DISPLAYED AN "ECG FAULT 7" MESSAGE.COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50567512 ↗MalfunctionSep 1, 2026No Display/Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50544082 ↗MalfunctionAug 31, 2026Failure of Device to Self-Test
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50520188 ↗MalfunctionAug 17, 2026Unable to Obtain Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50286341 ↗MalfunctionAug 12, 2026Failure to Deliver Shock/Stimulation
COMPLAINANT ALLEGED THAT DURING A ROUTINE SHIFT CHECK BY A CLINICIAN, THE DEVICE FAILED TO DISCHARGE.COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50222425 ↗MalfunctionAug 6, 2026Unexpected Shutdown
COMPLAINANT ALLEGED WHILE ATTEMPTING TO MONITOR A 67-YEAR-OLD MALE PATIENT, THE DEVICE INAPPROPRIATELY SHUT DOWN.COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION.THIS IS THE FIRST OF A SIMILAR REPORT. THE SECOND REPORTED ON MEDWATCH 1220908-2026-02913.
Patient problems: Insufficient Information
MAUDE report 50161755 ↗MalfunctionAug 6, 2026Defibrillation/Stimulation Problem
COMPLAINANT ALLEGED THAT DURING BIOMED TESTING, THE DEVICE DISPLAYED A "DEFIB FAULT 72" MESSAGE.COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50158615 ↗MalfunctionAug 6, 2026Unexpected Shutdown
COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT AN 67-YEAR-OLD MALE PATIENT, 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 50158253 ↗MalfunctionAug 6, 2026Failure 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 Clinical Signs, Symptoms or Conditions
MAUDE report 50156721 ↗MalfunctionJul 30, 2026Unable to Obtain Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50088314 ↗MalfunctionJul 30, 2026Pacing Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50088262 ↗MalfunctionJul 29, 2026Pacing Problem; Defibrillation/Stimulation Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50071039 ↗MalfunctionJul 29, 2026Defibrillation/Stimulation Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50068665 ↗MalfunctionJul 28, 2026Failure to Power Up
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50055062 ↗MalfunctionJul 27, 2026Defibrillation/Stimulation Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50036257 ↗MalfunctionJul 27, 2026Unable to Obtain Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50035189 ↗MalfunctionJul 20, 2026Defibrillation/Stimulation Problem
COMPLAINANT ALLEGED THAT DURING BIOMED TESTING, THE DEVICE DISPLAYED "PACER FAULT 115" MESSAGE. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25870281 ↗MalfunctionJul 20, 2026Grounding Malfunction
COMPLAINANT ALLEGED THAT DURING BIOMED TESTING, THE DEVICE FAILED LEAKAGE CURRENT TEST. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25870193 ↗MalfunctionJul 17, 2026Failure 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 Clinical Signs, Symptoms or Conditions
MAUDE report 25856379 ↗MalfunctionJul 16, 2026Unexpected Shutdown
COMPLAINANT ALLEGED THAT DURING BIOMED TESTING, THE DEVICE INAPPROPRIATELY SHUT DOWN. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25839480 ↗
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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.