BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK 15 MONITOR/DEFIBRILLATOR

    MDR report key: 2050075 · Received April 4, 2011

    Report

    Report Number
    3015876-2011-00298
    Event Type
    Malfunction
    Date Received
    April 4, 2011
    Date of Event
    March 3, 2011
    Report Date
    March 6, 2011
    Manufacturer
    PHYSIO-CONTROL, INC.
    Product Code
    MKJ
    PMA / PMN Number
    K082937
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): PHYSIO-CONTROL EVALUATED THE DEVICE AND VERIFIED THE REPORTED FAILURE. PHYSIO ISOLATED THE CAUSE OF THE REPORTED FAILURE TO A STUCK CHARGE BUTTON ON THE MAIN KEYPAD ASSEMBLY. AN ELECTRICAL SHORT OF THE CHARGE BUTTON INHIBITED THE ANALYZE, ENERGY SELECT, CHARGE AND SYNC BUTTONS OPERATION. PHYSIO WILL REPLACE THE MAIN KEYPAD ASSEMBLY AND RETURN THE DEVICE TO THE CUSTOMER FOR USE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SEVERAL CRITICAL BUTTONS (CHARGE, ANALYZE, ENERGY SELECT) OF THE DEVICE MAIN KEYPAD ASSEMBLY WERE INOPERATIVE. HENCE, THE DEVICE WAS NOT ABLE TO DELIVER DEFIBRILLATION THERAPY. THERE WAS NO PATIENT USE ASSOCIATED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFEPAK 15 MONITOR/DEFIBRILLATOR MKJ PHYSIO-CONTROL, INC. 15 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA