M SERIES 40010011000103011Recalls & reported problems
Zoll Medical Corporation · Defibrillator ,MAIN, BASIC-2 AC/PC/EL/SM/RCD, ENG · Class 3
All models of M SERIES (21)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00847946003562), received between Jul 27, 2017 and Jun 17, 2020 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Device Displays Incorrect Message” (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 Displays Incorrect Message1
- Failure to Deliver Energy1
- No Display/Image1
Patient problems
- No Patient Involvement2
- No Information1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 17, 2020No Display/Image; No Display/Image
COMPLAINANT ALLEGED THAT DURING BIOMED TESTING, THE DEVICE POWERED ON WITHOUT DISPLAY. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Patient Involvement
MAUDE report 10163641 ↗MalfunctionSep 24, 2018Failure to Deliver Energy; Failure to Deliver Energy
COMPLAINANT ALLEGED THAT DURING BIOMED TESTING, THE DEVICE FAILED TO DISCHARGE. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Patient Involvement
MAUDE report 7902682 ↗MalfunctionJul 27, 2017Device Displays Incorrect Message; Device Displays Incorrect Message
COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO CARDIOVERT A FEMALE PATIENT (AGE UNKNOWN) WITH HANDS FREE NON-ZOLL ELECTRODES, THE DEVICE PROMPTED A "WAVE FORM TOO SMALL" MESSAGE. CLINICIANS PROCEEDED TO INCREASED THE SIZE UNSUCCESSFULLY AND HAD TO USE TWO DEVICES BEFORE SUCCESSFULLY CONVERTING THE PATIENT. COMPLAINANT INDICATED THAT THE CLINICIAN OBTAINED ANOTHER DEVICE TO CONTINUE TREATING THE PATIENT. COMPLAINANT INDICATED THAT THERE WAS NO ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION.
Patient problems: No Information
MAUDE report 6747931 ↗
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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