BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK 12 DEFIBRILLATOR/MONITOR SERIES

    MDR report key: 1060524 · Received June 11, 2008

    Report

    Report Number
    3015876-2008-00594
    Event Type
    Malfunction
    Date Received
    June 11, 2008
    Date of Event
    May 14, 2008
    Report Date
    May 14, 2008
    Manufacturer
    PHYSIO-CONTROL, INC.
    Product Code
    MKJ
    PMA / PMN Number
    K991910
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PE
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    PHYSIO-CONTROL SUPPLIED PARTS INFORMATION TO CUSTOMER FOR REPAIR.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, THE DEVICE'S DISPLAY GOES TO ALL AMBER AFTER POWER-UP, THE DEVICE IS NON FUNCTIONAL, AND SEVERAL FAULT CODES RELATED TO THE SYSTEM PCB ASSEMBLY ARE LOGGED INTO DEVICE MEMORY. THERE WAS NO PATIENT ASSOCIATED WITH THE REPORTED EVENT.

    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