M SERIES BIPHASIC 40010011100123010Recalls & reported problems
Zoll Medical Corporation · Defibrillator ,MAIN,ACLS,3/5LEAD,BIPHASIC,AC,PC,EL,SM,RC,CDMK,ENG · Class 2
All models of M SERIES BIPHASIC (59)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Zoll M Series defibrillator has 247 reports on file, with 1 death and no injuries. Many describe the unit failing to power up, failing its self-test, or showing error messages during routine checks or biomedical testing, and most note no patient involvement. 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
- 247
- Deaths reported
- 1
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 247 adverse event reports that list this exact device (DI 00847946000684), received between Aug 13, 2015 and Jan 13, 2022 — classified as 1 death, 245 malfunctions.
The most frequently reported specific device problem is “Failure to Power Up” (51 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.
Most reported problems
Device problems
- Failure to Power Up51
- Device Displays Incorrect Message33
- Defibrillation/Stimulation Problem24
- Failure of Device to Self-Test20
- No Display/Image19
- Pacing Problem18
- Failure to Charge13
- Failure to Discharge11
Patient problems
- No Patient Involvement223
- No Information12
- No Consequences Or Impact To Patient9
- No Clinical Signs, Symptoms or Conditions2
- Death1
Recent adverse event reports
The 25 most recent of 247 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 13, 2022Defibrillation/Stimulation Problem; Defibrillation/Stimulation Problem
COMPLAINANT ALLEGED THAT DURING FUNCTIONAL 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 13254324 ↗MalfunctionAug 17, 2021No Display/Image; No Display/Image
COMPLAINANT ALLEGED THAT DURING A ROUTINE SHIFT CHECK BY A CLINICIAN, THE DEVICE POWERED ON WITHOUT DISPLAY. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12333273 ↗MalfunctionOct 14, 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 10678526 ↗MalfunctionAug 19, 2020Failure 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 10425135 ↗MalfunctionAug 17, 2020Pacing Problem; Pacing Problem
COMPLAINANT ALLEGED THAT DURING A ROUTINE SHIFT CHECK BY A CLINICIAN, THE DEVICE DISPLAYED A "PACER FAULT 117" MESSAGE. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Patient Involvement
MAUDE report 10417052 ↗MalfunctionJul 29, 2020Unable to Obtain Readings; Unable to Obtain Readings
COMPLAINANT ALLEGED THAT DURING BIOMED TESTING, THE DEVICE DISPLAYED A "POOR PAD CONTACT" MESSAGE. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Patient Involvement
MAUDE report 10338431 ↗MalfunctionJul 27, 2020Defibrillation/Stimulation Problem; Defibrillation/Stimulation Problem
COMPLAINANT ALLEGED THAT DURING A ROUTINE SHIFT CHECK BY A CLINICIAN, THE DEVICE 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 10326518 ↗MalfunctionJul 21, 2020Activation Problem; Activation Problem
COMPLAINANT ALLEGED THAT DURING BIOMED TESTING, THE DEVICE WAS UNABLE TO SWITCH INTO SYNC MODE. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Patient Involvement
MAUDE report 10302780 ↗MalfunctionJun 30, 2020Failure 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 10212094 ↗MalfunctionJun 11, 2020Defibrillation/Stimulation Problem; Defibrillation/Stimulation Problem
COMPLAINANT ALLEGED THAT WHILE A CLINICIAN WAS ATTEMPTING TO DEFIBRILLATE A (B)(6) YEAR-OLD MALE PATIENT, THE DEVICE DISPLAYED A "POOR PAD CONTACT" MESSAGE. COMPLAINANT INDICATED THAT THE CLINICIAN OBTAINED ANOTHER DEVICE TO CONTINUE TREATING THE PATIENT. COMPLAINANT INDICATED THAT THERE WAS NO ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10143886 ↗MalfunctionJun 1, 2020Defibrillation/Stimulation Problem; Defibrillation/Stimulation Problem
COMPLAINANT ALLEGED THAT DURING BIOMED TESTING, THE DEVICE DISPLAYED A "BRIDGE TEST FAILED" MESSAGE. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Patient Involvement
MAUDE report 10105994 ↗MalfunctionMay 14, 2020No Display/Image; No Display/Image
COMPLAINANT ALLEGED THAT DURING A ROUTINE SHIFT CHECK BY A CLINICIAN, 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 10057837 ↗MalfunctionMay 5, 2020Pacing Problem; Defibrillation/Stimulation Problem; Pacing Problem; Defibrillation/Stimulation Problem
COMPLAINANT ALLEGED THAT DURING A ROUTINE SHIFT CHECK BY A CLINICIAN, THE DEVICE DISPLAYED A "PACER FAULT 117" AND "DEFIB FAULT 72" MESSAGES. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Patient Involvement
MAUDE report 10025757 ↗MalfunctionApr 28, 2020Failure to Power Up; Failure to Power Up
COMPLAINANT ALLEGED THAT DURING BIOMED 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 10005867 ↗MalfunctionApr 22, 2020Pacing Problem; Pacing Problem
COMPLAINANT ALLEGED THAT DURING A ROUTINE SHIFT CHECK BY A CLINICIAN, THE DEVICE WAS UNABLE TO INCREASE PACER OUTPUT. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Patient Involvement
MAUDE report 9987364 ↗MalfunctionApr 22, 2020Pacing Problem; Defibrillation/Stimulation Problem; Pacing Problem; Defibrillation/Stimulation Problem
COMPLAINANT ALLEGED THAT DURING A ROUTINE SHIFT CHECK BY A CLINICIAN, THE DEVICE DISPLAYED "DEFIB FAULT 72" AND "PACER FAULT 116" MESSAGES. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Patient Involvement
MAUDE report 9987246 ↗MalfunctionApr 22, 2020No Display/Image; No Display/Image
COMPLAINANT ALLEGED THAT DURING BIOMED TESTING, THE DEVICE'S DISPLAY BLANKED OUT. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Patient Involvement
MAUDE report 9987168 ↗MalfunctionApr 17, 2020Failure to Power Up; Failure to Power Up
COMPLAINANT ALLEGED THAT DURING BIOMED 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 9974057 ↗MalfunctionApr 3, 2020Pacing Problem; Pacing Problem
COMPLAINANT ALLEGED THAT DURING BIOMED TESTING, THE DEVICE WAS UNABLE TO INCREASE PACER OUTPUT. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Patient Involvement
MAUDE report 9922438 ↗MalfunctionMar 23, 2020Pacing Problem; Pacing Problem
COMPLAINANT ALLEGED THAT DURING A ROUTINE SHIFT CHECK BY A CLINICIAN, THE DEVICE WAS UNABLE TO INCREASE PACER OUTPUT. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Patient Involvement
MAUDE report 9864714 ↗MalfunctionMar 2, 2020Defibrillation/Stimulation Problem; Defibrillation/Stimulation Problem
COMPLAINANT ALLEGED THAT DURING A ROUTINE SHIFT CHECK BY A CLINICIAN, THE DEVICE DISPLAYED A "BRIDGE TEST FAILED" MESSAGE. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Patient Involvement
MAUDE report 9776285 ↗MalfunctionMar 2, 2020Output Problem; Output Problem
COMPLAINANT ALLEGED THAT DURING BIOMED TESTING, THE DEVICE WAS UNABLE TO ADJUST PACER OUTPUT. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Patient Involvement
MAUDE report 9776229 ↗MalfunctionFeb 14, 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 9713159 ↗MalfunctionFeb 12, 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 9701079 ↗MalfunctionFeb 6, 2020Defibrillation/Stimulation Problem; Defibrillation/Stimulation Problem
COMPLAINANT ALLEGED THAT DURING BIOMED TESTING, THE DEVICE WAS UNABLE TO ANALYZE. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Patient Involvement
MAUDE report 9676812 ↗
Other PACEMAKER, CARDIAC, EXTERNAL TRANSCUTANEOUS (NON-INVASIVE) devices
- Tempus LS-MANUAL 3.940589Schiller AG · Pacemaker, Cardiac, External Transcutaneous (Non-Invasive)4 recalls34 deaths391 reports
- M SERIES BIPHASIC 40010511100123010Zoll Medical Corporation · PACEMAKER, CARDIAC, EXTERNAL TRANSCUTANEOUS (NON-INVASIVE)77 reports
- M SERIES BIPHASIC 40010011100103011Zoll Medical Corporation · PACEMAKER, CARDIAC, EXTERNAL TRANSCUTANEOUS (NON-INVASIVE)48 reports
- Medi-Trace Cadence 22550RCardinal Health, Inc. · Pacemaker, Cardiac, External Transcutaneous (Non-Invasive)1 death20 reports
- M SERIES BIPHASIC 40010711100123010Zoll Medical Corporation · PACEMAKER, CARDIAC, EXTERNAL TRANSCUTANEOUS (NON-INVASIVE)14 reports
- Medi-Trace Cadence 22770PCCardinal Health, Inc. · Pacemaker, Cardiac, External Transcutaneous (Non-Invasive)11 reports
- M SERIES BIPHASIC 60010011100123010Zoll Medical Corporation · PACEMAKER, CARDIAC, EXTERNAL TRANSCUTANEOUS (NON-INVASIVE)9 reports
- Medi-Trace Cadence 22550PCCardinal Health, Inc. · Pacemaker, Cardiac, External Transcutaneous (Non-Invasive)8 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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