BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK 500 AUTOMATED EXTERNAL DEFIBRILLATOR

    MDR report key: 1934052 · Received December 2, 2010

    Report

    Report Number
    3015876-2010-01316
    Event Type
    Malfunction
    Date Received
    December 2, 2010
    Date of Event
    November 4, 2010
    Report Date
    November 4, 2010
    Manufacturer
    PHYSIO-CONTROL, INC.
    Product Code
    MKJ
    PMA / PMN Number
    K983393
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE CUSTOMER DECLINED PHYSIO- CONTROL'S REPAIR OFFER AND OPTED TO PURCHASE A REPLACEMENT DEFIBRILLATOR. HENCE, THE DEVICE WAS RETURNED TO THE CUSTOMER IN THE OBSERVED CONDITION. FOLLOW UP WITH THE CUSTOMER CONFIRMED THAT THE DEVICE WILL BE REMOVED FROM SERVICE AND DISPOSED. A CONCLUSIVE CAUSE FOR THE MALFUNCTION COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THE DEVICE HAD THE WRENCH ICON ILLUMINATED. PHYSIO-CONTROL EVALUATED THE DEVICE AND OBSERVED THAT IT SHOWED THE SERVICE WRENCH AND THE "CALL SERVICE" MESSAGE. THE DEVICE LOCKED UP AND WAS NOT AVAILABLE TO PROVIDE DEFIBRILLATION THERAPY. THERE WAS NO PT 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