BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    M SERIES

    MDR report key: 291657 · Received August 17, 2000

    Report

    Report Number
    1220908-2000-00834
    Event Type
    Malfunction
    Date Received
    August 17, 2000
    Report Date
    July 19, 2000
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    KRF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    EMERGENCY MEDICAL TECHNICIAN

    Narratives

    Description of Event or Problem · 1

    THE COMPLAINANT ALLEGED THAT DURING ROUTINE TESTING OF THE DEVICE BY BIOMEDICAL, A "FAULT 78" MESSAGE WAS DISPLAYED ON THE SCREEN. THE COMPLAINANT INDICATED THERE WAS NO PT INVOLVEMENT WITH THIS 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