BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    M SERIES

    MDR report key: 376569 · Received February 7, 2002

    Report

    Report Number
    1220908-2002-00213
    Event Type
    Malfunction
    Date Received
    February 7, 2002
    Report Date
    January 10, 2002
    Manufacturer
    ZOLL MEDICAL CORP.
    Product Code
    MKJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THAT DURING BIOMED TESTING AND ROUTINE PREVENTATIVE MAINTENANCE OF THE DEVICE, THE SCREEN DISPLAYED PACER FAULTS 121, 122, 123 AND 126 WHEN THE UNIT WAS SET AT 30MA. THE COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other