BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK CR(R) PLUS DEFIBRILLATOR

    MDR report key: 3966301 · Received July 30, 2014

    Report

    Report Number
    3015876-2014-00871
    Event Type
    Malfunction
    Date Received
    July 30, 2014
    Date of Event
    March 5, 2014
    Report Date
    July 16, 2014
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    MKJ
    PMA / PMN Number
    K033275
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PHYSIO-CONTROL EVALUATED THE DEVICE AND VERIFIED THE REPORTED FAILURE. PHYSIO OBSERVED THAT AN INTERNAL HLC BATTERY, DESIGNATOR BT1 WAS ELECTRICALLY DAMAGED AND DEPLETES AT A HIGHER RATE. ONCE THE BATTERY IS DEPLETED, IT PUTS A HIGHER LOAD ON THE REMAINING TWO INTERNAL HLC BATTERIES, WHICH LEADS TO A FASTER OVERALL HLC DEPLETION RATE. THE CUSTOMER RECEIVED A REPLACEMENT DEVICE.

    Description of Event or Problem · 1

    THE CUSTOMER INITIALLY REPORTED THAT THEIR DEVICE WAS DISPLAYING ITS CHARGE-PAK ICON. AFTER AN EVALUATION OF THE DEVICE, IT WAS OBSERVED THAT THE INTERNAL HLC BATTERIES COULD NOT RETAIN A CHARGE AND THE DEVICE WOULD LIKELY NOT HAVE SUFFICIENT POWER AVAILABLE IN ORDER TO PROVIDE EFFECTIVE DEFIBRILLATION THERAPY. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    443839 LIFEPAK CR(R) PLUS DEFIBRILLATOR DEFIBRILLATORS, AUTOMATIC, EXTERNAL MKJ PHYSIO-CONTROL, INC CRPLUS

    Patients

    Seq Age Sex Outcome Treatment
    1