R SERIES 30001006201310012Recalls & reported problems
Zoll Medical Corporation · Defibrillator ,MAIN, R SERIES, ALS, 3/5 LD, STD ECG, AC PWR, NELLCOR, PACE, SPO2, NIBP, DMST · Class 3
All models of R SERIES (94)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 6
- Deaths reported
- 1
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00847946017576), received between Jul 13, 2017 and May 7, 2026 — classified as 1 death, 5 malfunctions.
The most frequently reported specific device problem is “Failure to Power Up” (2 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 Up2
- Pacing Problem2
- Defibrillation/Stimulation Problem1
- Failure to Charge1
- Unable to Obtain Readings1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- No Patient Involvement2
- Necrosis1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 7, 2026Pacing Problem
COMPLAINANT ALLEGED THAT DURING BIOMED TESTING, THE DEVICE DISPLAYED A "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 25111194 ↗MalfunctionMar 30, 2023Pacing Problem; Defibrillation/Stimulation Problem; Pacing Problem; Defibrillation/Stimulation Problem
COMPLAINANT ALLEGED THAT DURING BIOMED TESTING, THE DEVICE DISPLAYED "DEFIB FAULT 72" AND "PACER DISABLED" MESSAGES. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16645335 ↗MalfunctionSep 2, 2022Failure to Charge; Failure to Charge
COMPLAINANT ALLEGED THAT DURING A ROUTINE SHIFT CHECK BY A CLINICIAN, THE DEVICE FAILED TO CHARGE. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15351135 ↗DeathJun 23, 2021Unable to Obtain Readings; Unable to Obtain Readings
COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO DEFIBRILLATE A PATIENT (AGE & GENDER UNKNOWN), THE DEVICE WAS UNABLE TO OBTAIN AN ECG SIGNAL VIA ELECTRODE PADS. COMPLAINANT INDICATED THAT THE CLINICIAN OBTAINED ANOTHER DEVICE TO CONTINUE TREATING THE PATIENT. COMPLAINANT INDICATED THAT THE PATIENT SUBSEQUENTLY EXPIRED; HOWEVER, THEY DO NOT BELIEVE THIS WAS DEVICE ASSOCIATED.
Patient problems: Necrosis
MAUDE report 12053397 ↗MalfunctionSep 10, 2018Failure to Power Up; Failure to Power Up
COMPLAINANT ALLEGED THAT DURING BIOMED TESTING, THE DEVICE INTERMITTENTLY WOULD NOT POWER UP. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Patient Involvement
MAUDE report 7861174 ↗MalfunctionJul 13, 2017Failure to Power Up; Failure to Power Up
COMPLAINANT ALLEGED THAT DURING A ROUTINE SHIFT CHECK BY A CLINICIAN, THE DEVICE WAS INTERMITTENTLY UNABLE TO POWER ON. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Patient Involvement
MAUDE report 6711425 ↗
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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