M SERIES BIPHASIC 40021311110123010Recalls & reported problems
Zoll Medical Corporation · Defibrillator ,MAIN MANUAL 1,12LEAD,ETCO2,SPO2,AC,BLUETOOTH.BIPHASIC,PACE,EL,RCD,SMR,CDMK,ENG · 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 00847946005627), received between Aug 28, 2019 and Jun 19, 2020 — classified as 3 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
- Failure to Charge1
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.
MalfunctionJun 19, 2020Failure to Charge; Failure to Charge
COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO DEFIBRILLATE A MALE PATIENT (AGE UNKNOWN), THE DEVICE FAILED TO CHARGE. COMPLAINANT INDICATED THAT THE CLINICIAN OBTAINED ANOTHER DEVICE TO CONTINUE TREATING THE PATIENT AND WAS ABLE TO CHARGE AND DELIVER A SHOCK. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION.
Patient problems: No Information
MAUDE report 10173648 ↗MalfunctionOct 22, 2019Failure to Power Up; Failure to Power Up
COMPLAINANT ALLEGED THAT DURING BIOMED TESTING, 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 9219457 ↗MalfunctionAug 28, 2019Failure 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 8939000 ↗
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- 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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