M SERIES BIPHASIC 40010311101103010Recalls & reported problems
Zoll Medical Corporation · Defibrillator ,MAIN, BASIC-4, SPO2, ETCO2, BIPHASIC, EL, PACE, NELLCOR, RCD, SMR, CDMK, AC, 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 00847946003982), received between Jan 26, 2018 and Jan 26, 2018 — classified as 1 malfunction.
The most frequently reported specific device problem is “Failure to Discharge” (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 Discharge1
Patient problems
- No Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 26, 2018Failure to Discharge; Failure to Discharge
COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A PATIENT (AGE & GENDER UNKNOWN) THE DEVICE WAS UNABLE TO DISCHARGE. COMPLAINANT INDICATED THAT THE CLINICIAN CHANGED THE ELECTRODE PADS TO NO AVAIL. COMPLAINANT INDICATED THAT THE CLINICIAN THEN OBTAINED ANOTHER DEVICE TO CONTINUE TREATING THE PATIENT. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION.
Patient problems: No Information
MAUDE report 7222749 ↗
Other PACEMAKER, CARDIAC, EXTERNAL TRANSCUTANEOUS (NON-INVASIVE) devices
- Tempus LS-MANUAL 3.940589Schiller AG · Pacemaker, Cardiac, External Transcutaneous (Non-Invasive)4 recalls34 deaths391 reports
- M SERIES BIPHASIC 40010011100123010Zoll Medical Corporation · PACEMAKER, CARDIAC, EXTERNAL TRANSCUTANEOUS (NON-INVASIVE)1 death247 reports
- M SERIES BIPHASIC 40010511100123010Zoll Medical Corporation · PACEMAKER, CARDIAC, EXTERNAL TRANSCUTANEOUS (NON-INVASIVE)77 reports
- M SERIES BIPHASIC 40010011100103011Zoll Medical Corporation · PACEMAKER, CARDIAC, EXTERNAL TRANSCUTANEOUS (NON-INVASIVE)48 reports
- Medi-Trace Cadence 22550RCardinal Health, Inc. · Pacemaker, Cardiac, External Transcutaneous (Non-Invasive)1 death20 reports
- M SERIES BIPHASIC 40010711100123010Zoll Medical Corporation · PACEMAKER, CARDIAC, EXTERNAL TRANSCUTANEOUS (NON-INVASIVE)14 reports
- Medi-Trace Cadence 22770PCCardinal Health, Inc. · Pacemaker, Cardiac, External Transcutaneous (Non-Invasive)11 reports
- M SERIES BIPHASIC 60010011100123010Zoll Medical Corporation · PACEMAKER, CARDIAC, EXTERNAL TRANSCUTANEOUS (NON-INVASIVE)9 reports
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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