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R SERIES 30000004101110012Recalls & reported problems

Zoll Medical Corporation · Defibrillator ,MAIN, R SERIES, ALS, WI-FI, NELLCOR, 3/5 LD, STD ECG, AC PWR, PACE, SPO2, ETCO2, CF/USB, DMST · Class 3

Quick summary

This Zoll R Series defibrillator is a non-wearable automated external defibrillator used to restart a heart. The 37 reports mostly describe problems found during routine biomedical testing and shift checks with no patient involved: units failing self-tests, powering on with a blank or white screen, showing error messages such as "DEFIB FAULT" or "CHECK PADS," not charging, failing to detect attached cables, or not responding to controls. No deaths or injuries were reported. 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
37
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 37 adverse event reports that list this exact device (DI 00847946002602), received between Mar 20, 2017 and Oct 14, 2020 — classified as 37 malfunctions.

The most frequently reported specific device problem is “Defibrillation/Stimulation Problem” (10 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.

Most reported problems

Device problems

  • Defibrillation/Stimulation Problem10
  • No Display/Image7
  • Unable to Obtain Readings6
  • Failure of Device to Self-Test5
  • Device Displays Incorrect Message3
  • Failure to Power Up2
  • Grounding Malfunction2
  • Unexpected Shutdown2

Patient problems

  • No Patient Involvement37

Recent adverse event reports

The 25 most recent of 37 reports, in the reporter's own words as published by the FDA.

  • MalfunctionOct 14, 2020Defibrillation/Stimulation Problem; Defibrillation/Stimulation Problem

    COMPLAINANT ALLEGED THAT DURING BIOMED TESTING, THE DEVICE DISPLAYED "DEFIB FAULT 76" AND "DEFIB DISABLED" MESSAGES. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.

    Patient problems: No Patient Involvement

    MAUDE report 10678966 ↗
  • MalfunctionOct 7, 2020Failure of Device to Self-Test; Failure of Device to Self-Test

    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 10643642 ↗
  • MalfunctionSep 10, 2020Failure to Charge; Defibrillation/Stimulation Problem; Failure to Charge; Defibrillation/Stimulation Problem

    COMPLAINANT ALLEGED THAT DURING A ROUTINE SHIFT CHECK BY A CLINICIAN, THE DEVICE FAILED TO CHARGE AND DISPLAYED A "DEFIB FAULT 72" MESSAGE. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.

    Patient problems: No Patient Involvement

    MAUDE report 10515515 ↗
  • MalfunctionSep 3, 2020Failure of Device to Self-Test; Failure of Device to Self-Test

    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 10489092 ↗
  • MalfunctionJul 28, 2020No Display/Image; No Display/Image

    COMPLAINANT ALLEGED THAT DURING BIOMED TESTING, THE DEVICE POWERED ON WITHOUT DISPLAY. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.

    Patient problems: No Patient Involvement

    MAUDE report 10331756 ↗
  • MalfunctionJul 8, 2020Unable to Obtain Readings; Mechanics Altered; Activation Problem; Unable to Obtain Readings; Mechanics Altered; Activation Problem

    COMPLAINANT ALLEGED THAT DURING A ROUTINE SHIFT CHECK BY A CLINICIAN, THE DEVICE POWERED UP IN THE INCORRECT MODE, DISPLAYED A "CHECK PADS" MESSAGE AND DID NOT RESPOND TO THE FRONT PANEL CONTROLS. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.

    Patient problems: No Patient Involvement

    MAUDE report 10246192 ↗
  • MalfunctionJun 18, 2020Unable to Obtain Readings; Unable to Obtain Readings

    COMPLAINANT ALLEGED THAT DURING BIOMED TESTING, THE DEVICE WAS UNABLE TO DETECT THE ATTACHED MULTIFUNCTION CABLE. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.

    Patient problems: No Patient Involvement

    MAUDE report 10168083 ↗
  • MalfunctionJun 3, 2020No Display/Image; No Display/Image

    COMPLAINANT ALLEGED THAT DURING BIOMED 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 Patient Involvement

    MAUDE report 10115369 ↗
  • MalfunctionMay 15, 2020Defibrillation/Stimulation Problem; Defibrillation/Stimulation Problem

    COMPLAINANT ALLEGED THAT DURING A ROUTINE SHIFT CHECK BY A CLINICIAN, THE DEVICE DISPLAYED "DEFIB FAULT 76" AND " DEFIB DISABLED" MESSAGES. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.

    Patient problems: No Patient Involvement

    MAUDE report 10062459 ↗
  • MalfunctionMay 5, 2020Defibrillation/Stimulation Problem; Defibrillation/Stimulation Problem

    COMPLAINANT ALLEGED THAT DURING A ROUTINE SHIFT CHECK BY A CLINICIAN, THE DEVICE DISPLAYED A "DEFIB FAULT 76" MESSAGE. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.

    Patient problems: No Patient Involvement

    MAUDE report 10025836 ↗
  • MalfunctionApr 6, 2020Defibrillation/Stimulation Problem; Defibrillation/Stimulation Problem

    COMPLAINANT ALLEGED THAT DURING A ROUTINE SHIFT CHECK BY A CLINICIAN, THE DEVICE DISPLAYED A "DEFIB DISABLED" MESSAGE. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.

    Patient problems: No Patient Involvement

    MAUDE report 9928247 ↗
  • MalfunctionNov 27, 2019Unable to Obtain Readings; Unable to Obtain Readings

    COMPLAINANT ALLEGED THAT DURING A ROUTINE SHIFT CHECK BY A CLINICIAN, THE DEVICE DISPLAYED AN "ECG DISABLED" MESSAGE. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.

    Patient problems: No Patient Involvement

    MAUDE report 9384189 ↗
  • MalfunctionOct 29, 2019Defibrillation/Stimulation Problem; Defibrillation/Stimulation Problem

    COMPLAINANT ALLEGED THAT DURING BIOMED TESTING, THE DEVICE DISPLAYED "DEFIB FAULT 72" AND "DEFIB FAULT 76" MESSAGES. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.

    Patient problems: No Patient Involvement

    MAUDE report 9251245 ↗
  • MalfunctionSep 20, 2019No Display/Image; No Display/Image

    COMPLAINANT ALLEGED THAT DURING BIOMED TESTING, THE DEVICE'S DISPLAY WAS DISTORTED AND NO CLINICAL INFORMATION COULD BE SEEN. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.

    Patient problems: No Patient Involvement

    MAUDE report 9100418 ↗
  • MalfunctionSep 20, 2019Defibrillation/Stimulation Problem; Defibrillation/Stimulation Problem

    COMPLAINANT ALLEGED THAT DURING BIOMED TESTING, THE DEVICE DISPLAYED "DEFIB FAULT 76" AND "DEFIB DISABLED" MESSAGES. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.

    Patient problems: No Patient Involvement

    MAUDE report 9097550 ↗
  • MalfunctionJun 27, 2019Unable to Obtain Readings; Unable to Obtain Readings

    COMPLAINANT ALLEGED THAT DURING A ROUTINE SHIFT CHECK BY A CLINICIAN, THE DEVICE DISPLAYED AN "ECG DISABLED" MESSAGE. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.

    Patient problems: No Patient Involvement

    MAUDE report 8741158 ↗
  • MalfunctionJun 26, 2019Grounding Malfunction; Unexpected Shutdown; Grounding Malfunction; Unexpected Shutdown

    COMPLAINANT ALLEGED THAT DURING BIOMED TESTING, THE DEVICE FAILED LEAKAGE CURRENT TEST AND INAPPROPRIATELY SHUT DOWN. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.

    Patient problems: No Patient Involvement

    MAUDE report 8735852 ↗
  • MalfunctionJun 26, 2019Grounding Malfunction; Unexpected Shutdown; Grounding Malfunction; Unexpected Shutdown

    COMPLAINANT ALLEGED THAT DURING BIOMED TESTING, THE DEVICE FAILED LEAKAGE CURRENT TEST AND INAPPROPRIATELY SHUT DOWN. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.

    Patient problems: No Patient Involvement

    MAUDE report 8734703 ↗
  • MalfunctionJun 24, 2019Unable to Obtain Readings; Unable to Obtain Readings

    COMPLAINANT ALLEGED THAT DURING A ROUTINE SHIFT CHECK BY A CLINICIAN, THE DEVICE DISPLAYED AN "ECG DISABLED" MESSAGE. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.

    Patient problems: No Patient Involvement

    MAUDE report 8728826 ↗
  • MalfunctionMay 15, 2019Failure to Power Up; Failure to Power Up

    COMPLAINANT ALLEGED THAT DURING A ROUTINE SHIFT CHECK BY A CLINICIAN, 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 8612625 ↗
  • MalfunctionMay 2, 2019Defibrillation/Stimulation Problem; Defibrillation/Stimulation Problem

    COMPLAINANT ALLEGED THAT DURING BIOMED TESTING, THE DEVICE DISPLAYED A "DEFIB PAD SHORT" MESSAGE. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.

    Patient problems: No Patient Involvement

    MAUDE report 8573161 ↗
  • MalfunctionApr 5, 2019Unable to Obtain Readings; Unable to Obtain Readings

    COMPLAINANT ALLEGED THAT DURING BIOMED TESTING, THE DEVICE DISPLAYED A "ECG DISABLED" MESSAGE. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.

    Patient problems: No Patient Involvement

    MAUDE report 8486428 ↗
  • MalfunctionApr 2, 2019Failure of Device to Self-Test; Failure 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 Patient Involvement

    MAUDE report 8475350 ↗
  • MalfunctionMar 26, 2019No Display/Image; No Display/Image

    COMPLAINANT ALLEGED THAT DURING FUNCTIONAL TESTING, THE DEVICE'S SCREEN TURNED COMPLETELY WHITE AND WAS ILLEGIBLE. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.

    Patient problems: No Patient Involvement

    MAUDE report 8453266 ↗
  • MalfunctionMar 26, 2019Failure of Device to Self-Test; Failure 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 Patient Involvement

    MAUDE report 8452577 ↗

Other Automated external defibrillators (non-wearable) devices

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.