M SERIES BIPHASIC 60021511100123010Recalls & reported problems
Zoll Medical Corporation · Defibrillator ,MAIN,ACLS,MNL-1,12LEAD,SPO2,NIBP,BIPHASIC,EL,AC,PC,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
- 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 00847946014292), received between Jan 10, 2020 and Jan 10, 2020 — classified as 1 malfunction.
The most frequently reported specific device problem is “Pacing Problem” (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
- Pacing Problem1
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.
MalfunctionJan 10, 2020Pacing Problem; Pacing Problem
COMPLAINANT ALLEGED THAT DURING FUNCTIONAL TESTING, THE DEVICE DISPLAYED A "PACER FAULT 117" MESSAGE. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Patient Involvement
MAUDE report 9577811 ↗
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 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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