BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    M SERIES

    MDR report key: 1003194 · Received February 22, 2008

    Report

    Report Number
    1220908-2008-00353
    Event Type
    Malfunction
    Date Received
    February 22, 2008
    Report Date
    February 7, 2008
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    MKJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED MALFUNCTION WAS OBSERVED AND ATTRIBUTED TO A FAULTY CONTROL BOARD FLEX CABLE. THE CONTROL BOARD FLEX CABLE WAS REPLACED TO CORRECT THE REPORTED PROBLEM.

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THAT THE DEVICE'S PACER OUTPUT WAS NOT ADJUSTABLE. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY 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 CORPORATION MSERIES BI-PHASIC NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA