BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK CR(R) PLUS DEFIBRILLATOR

    MDR report key: 4220157 · Received November 3, 2014

    Report

    Report Number
    3015876-2014-01300
    Event Type
    Malfunction
    Date Received
    November 3, 2014
    Date of Event
    October 7, 2014
    Report Date
    October 7, 2014
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    MKJ
    PMA / PMN Number
    K033275
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    PHYSIO-CONTROL EVALUATED THE DEVICE AND VERIFIED THE REPORTED FAILURE. IT WAS OBSERVED THAT THE DEVICE WOULD NO LONGER POWER ON. PHYSIO-CONTROL CONTINUES TO INVESTIGATE THE REPORTED FAILURE AND WILL SUBMIT A SUPPLEMENTAL REPORT ON THIS EVENT TO THE FDA AS PROVIDED BY 21 CFR 803.56.

    Additional Manufacturer Narrative · 1

    PHYSIO-CONTROL FURTHER EVALUATED THE DEVICE AND DETERMINED THAT THE CAUSE OF THE REPORTED FAILURE WAS DUE TO CORROSION OF THE CHARGE-PAK¿ BATTERY CHARGER. THE CHARGE-PAK HAD CORROSION IN THE CASE AND ON JACK CONNECTOR, DESIGNATOR J201, WHICH CAUSED THE CELLS TO DEPLETE AND DAMAGE TO THE FLEX CONNECTOR, DESIGNATOR P201. THE CHARGE-PAK CONTACTS WERE ALSO DAMAGED. THE DEVICE WOULD NOT POWER ON TO CHARGE AND SHOCK DEFIBRILLATION ENERGY. A REPLACEMENT DEVICE WAS PROVIDED TO THE CUSTOMER UNDER WARRANTY.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE SHOWED THE CHARGE-PAK AND ATTENTION ICONS IN THE READINESS DISPLAY. UPON EVALUATION OF THE DEVICE BY PHYSIO-CONTROL IT WAS OBSERVED THAT THE DEVICE SHOWED THE CHARGE-PAK, ATTENTION AND SERVICE WRENCH ICONS IN THE READINESS DISPLAY. THE DEVICE WOULD NOT POWER ON. THERE WAS NO PATIENT US ASSOCIATED WITH THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    700809 LIFEPAK CR(R) PLUS DEFIBRILLATOR DEFIBRILLATORS, AUTOMATIC, EXTERNAL MKJ PHYSIO-CONTROL, INC CRPLUS

    Patients

    Seq Age Sex Outcome Treatment
    1