M SERIES BIPHASIC 60010211100124010Recalls & reported problems
Zoll Medical Corporation · Defibrillator ,MAIN,CCT,MANUAL-1,3/5 LEAD,SPO2,BIPHASIC,PACE,RCD,SMR,CDMK,AC,DMST,REFURB · Class 3
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 00847946013431), received between Aug 12, 2015 and Mar 19, 2018 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Device Stops Intermittently” (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 Stops Intermittently1
- Failure to Charge1
- Failure to Power Up1
Patient problems
- No Patient Involvement2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 19, 2018Failure to Power Up; Failure to Power Up
COMPLAINANT ALLEGED THAT DURING A ROUTINE SHIFT CHECK BY A CLINICIAN, THE DEVICE WOULD NOT POWER UP. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Patient Involvement
MAUDE report 7348727 ↗MalfunctionAug 12, 2015Failure to Charge; Device Stops Intermittently
COMPLAINANT ALLEGED THAT DURING BIOMED TESTING, THE DEVICE WAS INTERMITTENTLY UNABLE TO CHARGE ENERGY. COMPLAINANT INDICATED THAT THERE WAS NO PT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Patient Involvement
MAUDE report 5008451 ↗
Other Automated external defibrillators (non-wearable) devices
- NA 861290Philips Medical Systems Hsg · Automated External Defibrillators (Non-Wearable)12 deaths5,167 reports
- NA 861288Philips Medical Systems Hsg · Automated External Defibrillators (Non-Wearable)21 deaths5,015 reports
- NA 861289Philips Medical Systems Hsg · Automated External Defibrillators (Non-Wearable)7 deaths3,385 reports
- R SERIES 30001005201310012Zoll Medical Corporation · Automated external defibrillators (non-wearable)10 deaths1,720 reports
- PHILIPS HeartStart FRxPhilips Electronics North America Corporation · Automated external defibrillators (non-wearable)26 deaths1,586 reports
- LIFEPAK CR2 99512Physio-Control, Inc. · Automated external defibrillators (non-wearable)8 deaths1,502 reports
- Lifeline Configuration DDU-100ADefibtech, L.L.C. · Automated External Defibrillators (Non-Wearable)1 death1,285 reports
- PHILIPS HeartStart FR3Philips Electronics North America Corporation · Automated External Defibrillators (Non-Wearable)10 deaths1,188 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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