BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    M SERIES

    MDR report key: 373531 · Received January 16, 2002

    Report

    Report Number
    1220908-2002-00065
    Event Type
    Malfunction
    Date Received
    January 16, 2002
    Date of Event
    December 18, 2001
    Report Date
    December 18, 2001
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    MKJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    DURING ROUTINE RE CERTIFICATION OF THE DEVICE BY A ZOLL SERVICE TECHNICIAN, THE DEVICE DISPLAYED "PACER FAULT 121, 122, 123, AND 126" MESSAGES. THERE WAS NO PATIENT INVOLVEMENT DURING THE REPORTED MALFUNCTION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other