BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK 12 DEFIBRILLATOR/MONITOR SERIES

    MDR report key: 1003818 · Received February 26, 2008

    Report

    Report Number
    3015876-2008-00093
    Event Type
    Malfunction
    Date Received
    February 26, 2008
    Date of Event
    January 5, 2008
    Report Date
    February 26, 2008
    Manufacturer
    PHYSIO-CONTROL, INC.
    Product Code
    MKJ
    PMA / PMN Number
    K991910
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    PHYSIO-CONTROL EVALUATED THE DEVICE. THE ROOT CAUSE WAS DETERMINED TO BE DUE TO A FAILURE OF THE SYSTEM/MEMORY PCB ASSEMBLY. AFTER REPLACING THE SYSTEM/MEMORY PCB ASSEMBLY, PROPER OPERATION WAS CONFIRMED AND THE DEVICE WAS RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE LOCKED-UP. THERE WAS NO PT INVOLVED IN THE REPORTED INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFEPAK 12 DEFIBRILLATOR/MONITOR SERIES MKJ PHYSIO-CONTROL, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA