BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK 500 AUTOMATED EXTERNAL DEFIBRILLATOR

    MDR report key: 1190597 · Received October 3, 2008

    Report

    Report Number
    3015876-2008-01446
    Event Type
    Malfunction
    Date Received
    October 3, 2008
    Date of Event
    September 4, 2008
    Report Date
    September 4, 2008
    Manufacturer
    PHYSIO-CONTROL, INC.
    Product Code
    MKJ
    PMA / PMN Number
    K983393
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PHYSIO-CONTROL EVALUATED THE DEVICE AND VERIFIED THE REPORTED FAILURE. PHYSIO REPLACED THE MAIN PC ASSEMBLY AND THEN OBSERVED PROPER DEVICE OPERATION THROUGH FUNCTIONAL AND PERFORMANCE TESTING. THE DEVICE WAS RETURNED TO THE CUSTOMER FOR USE. PHYSIO-CONTROL FURTHER EVALUATED THE REPLACED ASSEMBLY AND DETERMINED THAT THE ROOT CAUSE OF THE REPORTED FAILURE WAS AN IC CHIP, DESIGNATOR U8, THAT WAS CAUSING THE ASSEMBLY TO BOOT UP TO A BLUE BAR AND THEN LOCK UP IN THAT STATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WOULD NOT POWER ON. THERE WAS NO PATIENT USE ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFEPAK 500 AUTOMATED EXTERNAL DEFIBRILLATOR MKJ PHYSIO-CONTROL, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA