BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK 500 AUTOMATED EXTERNAL DEFIBRILLATOR

    MDR report key: 1021911 · Received March 28, 2008

    Report

    Report Number
    3015876-2008-00239
    Event Type
    Malfunction
    Date Received
    March 28, 2008
    Date of Event
    February 27, 2008
    Report Date
    March 3, 2008
    Manufacturer
    PHYSIO-CONTROL, INC.
    Product Code
    MKJ
    PMA / PMN Number
    K955854
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    PHYSIO-CONTROL EVALUATED THE DEVICE, VERIFIED THE REPORTED INTERMITTENT FAILURE, AND OBSERVED INTERMITTENT OPERATION OF THE ON/OFF BUTTON. THE SWITCH WAS REPAIRED AND THEN PROPER DEVICE OPERATION WAS OBSERVED THROUGH FUNCTIONAL AND PERFORMANCE TESTING. THE DEVICE WAS RETURNED TO THE CUSTOMER FOR USE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WOULD NOT POWER ON. THERE WAS NO PATIENT INVOLVEMENT REPORTED 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