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M SERIES CCT 40010811101124010Recalls & reported problems

Zoll Medical Corporation · Defibrillator ,MAIN CCT,MAN-1,3/5 LEAD,SPO2,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
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 00847946004828), received between Oct 25, 2017 and Oct 9, 2020 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Activation Problem” (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

  • Activation Problem1
  • Defibrillation/Stimulation Problem1
  • Failure of Device to Self-Test1
  • Loss of Power1
  • No Display/Image1
  • Use of Device Problem1

Patient problems

  • No Patient Involvement4
  • No Information1

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

  • MalfunctionOct 9, 2020No Display/Image; Activation Problem; No Display/Image; Activation Problem

    COMPLAINANT ALLEGED THAT DURING BIOMED TESTING, THE DEVICE'S DISPLAY FLICKERED AND DID NOT RESPOND TO THE FRONT PANEL CONTROLS. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.

    Patient problems: No Patient Involvement

    MAUDE report 10655837 ↗
  • MalfunctionFeb 21, 2020Use of Device Problem; Use of Device Problem

    COMPLAINANT ALLEGED THAT DURING BIOMED TESTING, THE DEVICE POWERED UP IN THE INCORRECT MODE. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.

    Patient problems: No Patient Involvement

    MAUDE report 9738883 ↗
  • MalfunctionSep 10, 2019Defibrillation/Stimulation Problem; Defibrillation/Stimulation Problem

    COMPLAINANT ALLEGED THAT DURING BIOMED TESTING, THE DEVICE DISPLAYED A "DEFIB FAULT 72" MESSAGE. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.

    Patient problems: No Patient Involvement

    MAUDE report 8983369 ↗
  • MalfunctionApr 9, 2018Loss of Power; Loss of Power

    COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A PATIENT (AGE & GENDER UNKNOWN), THE DEVICE INAPPROPRIATELY SHUT DOWN. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION.

    Patient problems: No Information

    MAUDE report 7406121 ↗
  • MalfunctionOct 25, 2017Failure of Device to Self-Test; Failure of Device to Self-Test

    COMPLAINANT ALLEGED THAT DURING A ROUTINE SHIFT CHECK BY A CLINICIAN, THE DEVICE INTERMITTENTLY FAILED SELF-TEST. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.

    Patient problems: No Patient Involvement

    MAUDE report 6975985 ↗

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Sources and updates

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