M SERIES BIPHASIC 40021511110123010Recalls & reported problems
Zoll Medical Corporation · Defibrillator ,MAIN,ACLS,MNL-1,12LEAD,SPO2,NIBP,BIPHASIC,EL,AC,PC,RC,SM,CM,BLUETOOTH,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 00847946006235), received between Jan 24, 2018 and Jan 24, 2018 — classified as 1 malfunction.
The most frequently reported specific device problem is “Energy 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
- Energy 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.
MalfunctionJan 24, 2018Energy Output Problem; Energy Output Problem
COMPLAINANT ALLEGED THAT DURING BIOMED TESTING, THE DEVICE'S PACER OUTPUT WAS OUT OF SPECIFICATION. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Patient Involvement
MAUDE report 7215396 ↗
Other ELECTROCARDIOGRAPH devices
- ELI 380 ELI380-DCS11Mortara Instrument, Inc. · Electrocardiograph1 recall1 death70 reports
- 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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