M SERIES BIPHASIC 40010711100103010Recalls & reported problems
Zoll Medical Corporation · Defibrillator ,MAIN,BASIC-4, 3/5LEAD,ETCO2,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
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00847946004613), received between Apr 5, 2017 and Sep 17, 2018 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Failure to Capture” (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
- Failure to Capture1
- Failure to Power Up1
Patient problems
- No Consequences Or Impact To Patient1
- No Patient Involvement1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 17, 2018Failure to Capture; Failure to Capture
COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO PACE A MALE PATIENT (AGE UNKNOWN), THE DEVICE FAILED TO CAPTURE THE PATIENT'S HEART RHYTHM. COMPLAINANT INDICATED THAT THE CLINICIAN OBTAINED ANOTHER DEVICE TO CONTINUE TREATING THE PATIENT. COMPLAINANT INDICATED THAT THERE WAS NO ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION. PLEASE REFERENCE MEDWATCH REPORT 1220908-2018-02627 FOR A SIMILAR EVENT REPORTED ON THE SAME PATIENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7882597 ↗MalfunctionApr 5, 2017Failure to Power Up; Failure to Power Up
COMPLAINANT ALLEGED THAT DURING BIOMED TESTING, THE DEVICE WAS UNABLE TO POWER ON. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Patient Involvement
MAUDE report 6461619 ↗
Other PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAPERITONEAL devices
- M SERIES BIPHASIC 40021711100123010Zoll Medical Corporation · PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAPERITONEAL6 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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