M SERIES BIPHASIC 40010511101124010Recalls & reported problems
Zoll Medical Corporation · Defibrillator ,MAIN,CCT,MANUAL-1,3/5 LEAD,SPO2,NIBP,BIPHASIC,PACE,RCD,SMR,CDMK,AC,NELLCOR,DMST · 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 00847946004224), received between Aug 21, 2015 and Aug 21, 2015 — classified as 1 malfunction.
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
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.
MalfunctionAug 21, 2015Device Operational Issue
COMPLAINANT ALLEGED THAT DURING BIOMED TESTING, THE DEVICE POWERED UP IN THE INCORRECT MODE. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Patient Involvement
MAUDE report 5032845 ↗
Other PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAPERITONEAL devices
- M SERIES BIPHASIC 40021711100123010Zoll Medical Corporation · PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAPERITONEAL6 reports
- 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 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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