BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    M SERIES

    MDR report key: 288934 · Received August 4, 2000

    Report

    Report Number
    1220908-2000-00779
    Event Type
    Malfunction
    Date Received
    August 4, 2000
    Report Date
    July 5, 2000
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    KRF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THAT DURING A ROUTINE SHIFT CHECK BY A CLINICIAN, THE DEVICE DISPLAYED A "ECU CRC" FAILURE UPON POWER UP. THERE WAS NO PT INVOLVEMENT DURING THE REPORTED MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 M SERIES DEFIBRILLATOR/PACEMAKER KRF ZOLL MEDICAL CORPORATION MSERIES NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other