BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    M SERIES

    MDR report key: 294325 · Received August 31, 2000

    Report

    Report Number
    1220908-2000-00925
    Event Type
    Malfunction
    Date Received
    August 31, 2000
    Report Date
    August 10, 2000
    Manufacturer
    ZOLL MEDICAL CORP.
    Product Code
    KRF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE PRODUCT WAS RETURNED TO ZOLL FOR SERVICE, DURING EVAL OF THE DEVICE, THE DEVICE DISPLAYED "DEFIB FAULT 108" AND "DEFIB FAULT 80" MESSAGES. THERE WAS NO PT INVOLVEMENT IN 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