BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK CR(R) PLUS DEFIBRILLATOR

    MDR report key: 3880177 · Received June 18, 2014

    Report

    Report Number
    3015876-2014-00669
    Event Type
    Malfunction
    Date Received
    June 18, 2014
    Date of Event
    May 20, 2014
    Report Date
    May 21, 2014
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    MKJ
    PMA / PMN Number
    K033275
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PHYSIO-CONTROL EVALUATED THE DEVICE AND VERIFIED THE REPORTED FAILURE. IT WAS OBSERVED THAT THE DEVICE DISPLAYED THE SERVICE WRENCH AND CHARGE-PAK ICONS AND THAT THE DEVICE HAD LOGGED SEVERAL EVENT CODES INTO THE MEMORY LOG. THE DEVICE WOULD CONTINUE TO DETECT MOTION AND COULD THEREFORE NOT CHARGE AND DEFIBRILLATION ENERGY. DUE TO THE DEVICE BEING OUT OF ITS WARRANTY PERIOD, THE CUSTOMER OPTED TO NOT RELEASE THE DEVICE FOR FURTHER EVALUATION, BUT TO REQUEST THE DEVICE TO BE RETURNED UNREPAIRED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO PHYSIO-CONTROL SERVICE THAT THEIR DEVICE SHOWED A SERVICE WRENCH ICON IN THE READINESS DISPLAY. DURING EVALUATION, IT WAS OBSERVED THAT THE DEVICE WOULD CONTINUOUSLY DETECT MOTION AND WOULD THEREFORE NOT BE ABLE TO CHARGE AND SHOCK DEFIBRILLATION ENERGY WHEN REQUIRED. SEVERAL EVENT CODES HAD BEEN LOGGED INTO THE DEVICE'S MEMORY. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    357969 LIFEPAK CR(R) PLUS DEFIBRILLATOR DEFIBRILLATORS, AUTOMATIC, EXTERNAL MKJ PHYSIO-CONTROL, INC CRPLUS

    Patients

    Seq Age Sex Outcome Treatment
    1