M SERIES CCT 40010911101124010Recalls & reported problems
Zoll Medical Corporation · Defibrillator ,MAIN,CCT,MAN-1,3/5 LEAD,SPO2,ETCO2,NIBP,IBP,TEMP,BIPHSC,PACE,RCD,SMR,CDMK,AC,DMST,NELLCOR · Class 2
All models of M SERIES CCT (10)
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 00847946004873), received between Apr 7, 2017 and Mar 15, 2018 — classified as 2 malfunctions.
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
- No Display/Image1
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 15, 2018No Display/Image; No Display/Image
COMPLAINANT ALLEGED THAT DURING FUNCTIONAL TESTING, THE DEVICE'S DISPLAY BLANKED OUT. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Patient Involvement
MAUDE report 7340807 ↗MalfunctionApr 7, 2017Failure to Power Up; Failure to Power Up
COMPLAINANT ALLEGED THAT DURING BIOMED TESTING THE DEVICE WAS UNABLE TO POWER ON. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Patient Involvement
MAUDE report 6472733 ↗
Other COMPUTER, BLOOD-PRESSURE devices
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- M SERIES CCT 40010811100124010Zoll Medical Corporation · COMPUTER, BLOOD-PRESSURE3 deaths72 reports
- AVVIGO™+ H7492493121C0Boston Scientific Corporation · COMPUTER, BLOOD-PRESSURE1 recall0 reports
- SureSigns VS2+ 863278Philips Medical Systems Hsg · COMPUTER, BLOOD-PRESSURE40 reports
- SureSigns VSi 863276Philips Medical Systems Hsg · COMPUTER, BLOOD-PRESSURE21 reports
- M SERIES CCT 40021911100124010Zoll Medical Corporation · COMPUTER, BLOOD-PRESSURE17 reports
- SureSigns VS2+ 863279Philips Medical Systems Hsg · COMPUTER, BLOOD-PRESSURE16 reports
- M SERIES CCT 40010911100124010Zoll Medical Corporation · COMPUTER, BLOOD-PRESSURE8 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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