BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK CR(R) PLUS DEFIBRILLATOR

    MDR report key: 3140459 · Received May 31, 2013

    Report

    Report Number
    3015876-2013-00459
    Event Type
    Malfunction
    Date Received
    May 31, 2013
    Date of Event
    April 11, 2013
    Report Date
    May 7, 2013
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    MKJ
    PMA / PMN Number
    K033275
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PHYSIO-CONTROL EVALUATED THE CUSTOMER¿S DEVICE AND VERIFIED THE REPORTED FAILURE. IT WAS DETERMINED THAT THE CAUSE OF THE REPORTED FAILURE WAS AN ELECTRICALLY LEAKY FILTER, DESIGNATOR FL10, ON THE ANALOG PCB ASSEMBLY. THE CUSTOMER WAS PROVIDED WITH A REPLACEMENT DEVICE.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE HAD A CHARGE-PAK AND ATTENTION ICON PRESENT ON THE DISPLAY. UPON EXAMINATION OF THE DEVICE, PHYSIO-CONTROL OBSERVED THAT ALL THREE ICONS (CHARGE PAK, ATTENTION AND SERVICE WRENCH) WERE PRESENT ON THE DISPLAY AND THAT THE DEVICE WOULD NO LONGER POWER ON. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    242328 LIFEPAK CR(R) PLUS DEFIBRILLATOR DEFIBRILLATORS, AUTOMATIC, EXTERNAL MKJ PHYSIO-CONTROL, INC CRPLUS

    Patients

    Seq Age Sex Outcome Treatment
    1