BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    M SERIES

    MDR report key: 290644 · Received August 11, 2000

    Report

    Report Number
    1220908-2000-00803
    Event Type
    Malfunction
    Date Received
    August 11, 2000
    Report Date
    July 14, 2000
    Manufacturer
    ZOLL MEDICAL CORP.
    Product Code
    KRF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THAT DURING INCOMING INSPECTION OF THE PRODUCT, THE DEVICE SHUT OFF WHILE ATTEMPTING TO CHARGE TO 30 JOULES AND WOULD NOT RE-POWER. 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