M SERIES BIPHASIC 60021011100163010Recalls & reported problems
Zoll Medical Corporation · Defibrillator ,MAIN,AED 12LEAD/BIPHASIC/AC/PC/EL/RC/SM/CDMK,REFURB · 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
- 1
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00847946013813), received between Mar 12, 2018 and Mar 14, 2019 — classified as 1 death, 1 malfunction.
The most frequently reported specific device problem is “Failure to Power Up” (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 Power Up1
- Unable to Obtain Readings1
Patient problems
- Death1
- 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.
DeathMar 14, 2019Unable to Obtain Readings; Unable to Obtain Readings
COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO DEFIBRILLATE A (B)(6) MALE PATIENT, THE DEVICE DISPLAYED A "DEFIB PAD SHORT" MESSAGE. COMPLAINANT INDICATED THAT THE CLINICIAN OBTAINED ANOTHER DEVICE AND ELECTRODE PADS TO CONTINUE TREATING THE PATIENT AND RECEIVED THE SAME ERROR. COMPLAINANT INDICATED THAT THE PATIENT SUBSEQUENTLY EXPIRED. PLEASE REFERENCE MEDWATCH REPORT 1220908-2019-00628 FOR THE OTHER DEFIBRILLATOR USED IN THE EVENT.
Patient problems: Death
MAUDE report 8420089 ↗MalfunctionMar 12, 2018Failure to Power Up; Failure to Power Up
COMPLAINANT ALLEGED THAT DURING FUNCTIONAL TESTING, THE DEVICE WOULD INTERMITTENTLY NOT POWER UP. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Patient Involvement
MAUDE report 7330998 ↗
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 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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