BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK CR(R) PLUS DEFIBRILLATOR

    MDR report key: 3072919 · Received April 23, 2013

    Report

    Report Number
    3015876-2013-00326
    Event Type
    Malfunction
    Date Received
    April 23, 2013
    Date of Event
    March 26, 2013
    Report Date
    March 26, 2013
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    MKJ
    PMA / PMN Number
    K033275
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): PHYSIO-CONTROL EVALUATED THE DEVICE AND VERIFIED THE REPORTED ISSUE. AFTER AN EVALUATION OF THE DEVICE, IT WAS OBSERVED THAT THE CHARGE-PAK INSTALLED INTO THE DEVICE HAD EXPIRED IN NOVEMBER OF 2010. THE CHARGE-PAK IS USED TO CHARGE THE INTERNAL HLC BATTERIES AND NEEDS TO BE MAINTAINED PER THE OPERATING INSTRUCTIONS. A CONCLUSIVE CAUSE OF THE REPORTED FAILURE COULD NOT BE DETERMINED. THE CUSTOMER RECEIVED A REPLACEMENT DEVICE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEIR DEVICE WAS SHOWING ALL THREE ICONS (ATTENTION, SERVICE WRENCH AND CHARGE-PAK) AND WOULD NOT POWER ON. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    175095 LIFEPAK CR(R) PLUS DEFIBRILLATOR DEFIBRILLATORS, AUTOMATIC, EXTERNAL MKJ PHYSIO-CONTROL, INC CRPLUS

    Patients

    Seq Age Sex Outcome Treatment
    1