M SERIES BIPHASIC 60010511100123010Recalls & reported problems
Zoll Medical Corporation · Defibrillator ,MAIN,ACLS/MNL-1, 3/5LEAD,SPO2,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
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00847946012069), received between May 24, 2017 and Jan 9, 2020 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Device Operational Issue” (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 Operational Issue1
- Failure to Select Signal1
- Pacing Problem1
Patient problems
- No Patient Involvement2
- No Information1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 9, 2020Failure to Select Signal; Failure to Select Signal
COMPLAINANT ALLEGED THAT DURING BIOMED TESTING, THE DEVICE WAS INTERMITTENTLY UNABLE TO SELECT ENERGY LEVEL. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Patient Involvement
MAUDE report 9569286 ↗MalfunctionFeb 6, 2018Pacing Problem; Pacing Problem
COMPLAINANT ALLEGED THAT DURING BIOMED TESTING THE DEVICE WAS UNABLE TO PACE. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Patient Involvement
MAUDE report 7245373 ↗MalfunctionMay 24, 2017Device Operational Issue; Device Operational Issue
COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A PATIENT (AGE & GENDER UNKNOWN) THE DEVICE WAS UNABLE TO ENTER DEFIB MODE. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION.
Patient problems: No Information
MAUDE report 6589263 ↗
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- 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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