M SERIES BIPHASIC 60010711100123010Recalls & reported problems
Zoll Medical Corporation · Defibrillator ,MAIN,ACLS/MNL-1, 3/5LEAD,SPO2,ETCO2,NIBP,BIPHASIC,AC,PC,EL,RC,SM,CM,ENG,REFURB · Class 2
All models of M SERIES BIPHASIC (59)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00847946013455), received between Oct 19, 2017 and Nov 20, 2017 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Device Displays Incorrect Message” (1 report).
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
- Device Displays Incorrect Message1
- Failure to Power Up1
Patient problems
- No Patient Involvement2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 20, 2017Device Displays Incorrect Message; Device Displays Incorrect Message
COMPLAINANT ALLEGED THAT DURING BIOMED TESTING, THE DEVICE DISPLAYED "DEFIB FAULT 78" AND "DEFIB FAULT 79" MESSAGES. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Patient Involvement
MAUDE report 7044495 ↗MalfunctionOct 19, 2017Failure 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 6960759 ↗
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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