M SERIES CCT 60021911100124010Recalls & reported problems
Zoll Medical Corporation · Defibrillator ,MAIN,CCT,MAN-1,12 LEAD,SPO2,ETCO2,NIBP,IBP,TEMP,BIP,PACE,RCD,SMR,CDMK,AC,DMST, REFURB · Class 2
All models of M SERIES CCT (10)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00847946014421), received between Sep 11, 2017 and Sep 22, 2020 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Failure to Power Up” (2 reports).
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 Up2
- No Display/Image2
- Unable to Obtain Readings1
- Unexpected Shutdown1
Patient problems
- No Patient Involvement5
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 22, 2020No Display/Image; No Display/Image
COMPLAINANT ALLEGED THAT DURING BIOMED TESTING, THE DEVICE'S DISPLAY WAS FLICKERING AND WAS ILLEGIBLE. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Patient Involvement
MAUDE report 10567143 ↗MalfunctionOct 10, 2019Unable to Obtain Readings; Unexpected Shutdown; Unable to Obtain Readings; Unexpected Shutdown
COMPLAINANT ALLEGED THAT DURING FUNCTIONAL TESTING, THE DEVICE DISPLAYED A "POOR PAD CONTACT" MESSAGE AND INAPPROPRIATELY SHUT DOWN. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Patient Involvement
MAUDE report 9177476 ↗MalfunctionOct 31, 2017Failure to Power Up; Failure to Power Up
COMPLAINANT ALLEGED THAT 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 6990152 ↗MalfunctionOct 10, 2017Failure to Power Up; Failure to Power Up
COMPLAINANT ALLEGED THAT THE DEVICE WOULD INTERMITTENTLY NOT POWER UP. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Patient Involvement
MAUDE report 6938444 ↗MalfunctionSep 11, 2017No Display/Image; No Display/Image
COMPLAINANT ALLEGED THAT THE DEVICE'S LEFT SIDE OF THE DISPLAY WAS MISSING CLINICAL INFORMATION. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Patient Involvement
MAUDE report 6855414 ↗
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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