BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK 500 AUTOMATED EXTERNAL DEFIBRILLATOR

    MDR report key: 2141349 · Received June 1, 2011

    Report

    Report Number
    3015876-2011-00426
    Event Type
    Malfunction
    Date Received
    June 1, 2011
    Date of Event
    May 3, 2011
    Report Date
    May 3, 2011
    Manufacturer
    PHYSIO-CONTROL, INC.
    Product Code
    MKJ
    PMA / PMN Number
    K955854
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PHYSIO-CONTROL PROVIDED THE CUSTOMER TECHNICAL ASSISTANCE AND DEVICE REPAIR OPTIONS. FOLLOW UP WITH THE REPORTER FOUND THAT THE DEVICE WAS REMOVED FROM SERVICE AND SCRAPPED AS THE CUSTOMER PURCHASED A REPLACEMENT DEFIBRILLATOR. THE DEVICE WAS NOT RETURNED TO PHYSIO-CONTROL FOR EVALUATION. THEREFORE, THE CAUSE OF THE REPORTED FAILURE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE GAVE THE "CALL SERVICE" MESSAGE AND LOGGED A CRITICAL EVENT CODE IN THE MEMORY. THE DEVICE WOULD NOT BE ABLE TO DELIVER DEFIBRILLATION THERAPY IN THE REPORTED CONDITION. THERE WAS NO PATIENT USE ASSOCIATED WITH THE 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