BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK 12 DEFIBRILLATOR/MONITOR SERIES

    MDR report key: 1052218 · Received May 21, 2008

    Report

    Report Number
    3015876-2008-00519
    Event Type
    Malfunction
    Date Received
    May 21, 2008
    Date of Event
    April 24, 2008
    Report Date
    April 24, 2008
    Manufacturer
    PHYSIO-CONTROL, INC.
    Product Code
    MKJ
    PMA / PMN Number
    K991910
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PHYSIO-CONTROL IS CONTINUING TO INVESTIGATE THE REPORTED INCIDENT.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, WHEN THE DEVICE WAS TURNED ON, IT LOCKED UP DURING BOOT-UP AT THE AMBER COLORED SCREEN AND WERE NOT ABLE TO TURN IT OFF BY PRESSING THE POWER BUTTON. THE BIOMED HAS BEEN UNABLE TO REPLICATE THE REPORTED MALFUNCTION.

    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 UNK