BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    M SERIES

    MDR report key: 292004 · Received August 18, 2000

    Report

    Report Number
    1220908-2000-00852
    Event Type
    Malfunction
    Date Received
    August 18, 2000
    Manufacturer
    ZOLL MEDICAL CORP.
    Product Code
    KRF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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 INTERMITTENTLY DID NOT DISPLAY A "TEST OKAY" MESSAGE WITH PADDLES, AND DISPLAYED EXCESSIVE "NOISE". 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 CORP. MSERIES NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other