M SERIES BIPHASIC 40010511100103010Recalls & reported problems
Zoll Medical Corporation · Defibrillator ,MAIN,BASIC-4, 3/5LEAD,SPO2,NIBP,BIPHASIC,AC,PC,EL,RC,SM,CM,ENG · Class 2
All models of M SERIES BIPHASIC (59)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00847946004163), received between Aug 19, 2015 and Oct 17, 2019 — classified as 6 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.
Most reported problems
Device problems
- Failure to Power Up2
- Energy Output Problem1
- Failure of Device to Self-Test1
- Failure to Charge1
- Use of Incorrect Control/Treatment Settings1
Patient problems
- No Patient Involvement5
- No Information1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 17, 2019Failure 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 Patient Involvement
MAUDE report 9203778 ↗MalfunctionAug 9, 2018Energy Output Problem; Energy Output Problem
COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A PATIENT (AGE AND GENDER UNKNOWN), THE DEVICE DID NOT FOLLOW CORRECT CHARGING PROTOCOL. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION.
Patient problems: No Information
MAUDE report 7769018 ↗MalfunctionNov 20, 2017Failure 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 7045700 ↗MalfunctionOct 30, 2017Failure to Power Up; Failure to Power Up
COMPLAINANT ALLEGED THAT 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 6986872 ↗MalfunctionMay 23, 2017Failure to Power Up; Failure to Power Up
COMPLAINANT ALLEGED THAT DURING BIOMED TESTING A BATTERY WAS UNABLE TO BE SEATED IN THE BATTERY WELL TO POWER THE DEVICE ON. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Patient Involvement
MAUDE report 6586161 ↗MalfunctionAug 19, 2015Use of Incorrect Control/Treatment Settings
COMPLAINANT ALLEGED THAT DURING BIOMED TESTING, THE DEVICE POWERED UP IN THE INCORRECT MODE AND WAS UNABLE TO SWITCH FROM LEADS TO PADS. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Patient Involvement
MAUDE report 5035710 ↗
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 40010011100123010Zoll Medical Corporation · PACEMAKER, CARDIAC, EXTERNAL TRANSCUTANEOUS (NON-INVASIVE)1 death247 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
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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