M SERIES BIPHASIC 40021711100123010Recalls & reported problems
Zoll Medical Corporation · Defibrillator ,MAIN,ACLS/MNL-1,12LEAD,SPO2,ETCO2,NIBP,BIPHASIC,EL,AC,PC,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
- 6
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00847946007065), received between Jun 8, 2015 and Aug 28, 2019 — classified as 6 malfunctions.
The most frequently reported specific device problem is “Failure to Power Up” (3 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 Up3
- Defibrillation/Stimulation Problem1
- Device Displays Incorrect Message1
- Output Problem1
Patient problems
- No Patient Involvement6
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 28, 2019Output Problem; Output Problem
COMPLAINANT ALLEGED THAT DURING BIOMED TESTING, THE DEVICE WAS UNABLE TO ADJUST PACER RATE AND PACER OUTPUT . COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Patient Involvement
MAUDE report 8939042 ↗MalfunctionSep 25, 2018Defibrillation/Stimulation Problem; Defibrillation/Stimulation Problem
COMPLAINANT ALLEGED THAT DURING BIOMED TESTING, THE DEVICE DISPLAYED A "BRIDGE TEST FAILED" MESSAGE. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Patient Involvement
MAUDE report 7906866 ↗MalfunctionFeb 14, 2018Failure to Power Up; Failure to Power Up
COMPLAINANT ALLEGED THAT DURING BIOMED TESTING, THE DEVICE WOULD INTERMITTENTLY NOT POWER UP. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Patient Involvement
MAUDE report 7270223 ↗MalfunctionFeb 7, 2018Device Displays Incorrect Message; Device Displays Incorrect Message
COMPLAINANT ALLEGED THAT DURING A ROUTINE SHIFT CHECK BY A CLINICIAN, THE DEVICE DISPLAYED A "FAULT 37" MESSAGE. NO FURTHER INFORMATION WAS AVAILABLE. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Patient Involvement
MAUDE report 7248110 ↗MalfunctionMay 5, 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 6547405 ↗MalfunctionJun 8, 2015Failure to Power Up
COMPLAINANT ALLEGED THAT DURING A ROUTINE SHIFT CHECK BY A CLINICIAN, THE DEVICE WAS INTERMITTENTLY UNABLE TO POWER ON. COMPLAINANT INDICATED THAT THERE WAS NO PT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Patient Involvement
MAUDE report 4841899 ↗
Other PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAPERITONEAL devices
- M SERIES BIPHASIC 40010711100103010Zoll Medical Corporation · PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAPERITONEAL2 reports
- M SERIES BIPHASIC 60021011100163010Zoll Medical Corporation · PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAPERITONEAL1 death2 reports
- M SERIES BIPHASIC 60021511100123010Zoll Medical Corporation · PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAPERITONEAL1 report
- M SERIES BIPHASIC 40010511101124010Zoll Medical Corporation · PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAPERITONEAL1 report
- M SERIES BIPHASIC 40021311100123010Zoll Medical Corporation · PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAPERITONEAL1 report
- M SERIES BIPHASIC 40010511100023010Zoll Medical Corporation · PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAPERITONEAL1 report
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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