M SERIES BIPHASIC 40010511100163010Recalls & reported problems
Zoll Medical Corporation · Defibrillator ,MAIN,EMTD-1,AED,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
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00847946004194), received between May 30, 2019 and May 30, 2019 — classified as 1 malfunction.
The most frequently reported specific device problem is “Output Problem” (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
- Output Problem1
Patient problems
- No Patient Involvement1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 30, 2019Output Problem; Output Problem
COMPLAINANT ALLEGED THAT DURING FUNCTIONAL TESTING, THE DEVICE'S PACER OUTPUT WAS OUT OF SPECIFICATION. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Patient Involvement
MAUDE report 8654906 ↗
Other ELECTROCARDIOGRAPH devices
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- Cardiac Workstation Cardiac Workstation 7000Philips Medizin Systeme Böblingen GmbH · Electrocardiograph2 recalls17 reports
- Q-Stress QSERV-6AA-XXXXBMortara Instrument, Inc. · Electrocardiograph2 recalls1 report
- Cardiac Workstation Cardiac Workstation 5000Philips Medizin Systeme Böblingen GmbH · Electrocardiograph2 recalls1 report
- MAC VU360GE Medical Systems Information Technologies, Inc. · Electrocardiograph2 recalls1 report
- XScribe Cardiopulmonary Kit 41000-030-60Mortara Instrument, Inc. · Electrocardiograph2 recalls0 reports
- Welch Allyn, Inc. 901049Welch Allyn, Inc. · ELECTROCARDIOGRAPH2 recalls0 reports
- Welch Allyn, Inc. 901133Welch Allyn, Inc. · Electrocardiograph2 recalls0 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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