BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK CR PLUS DEFIBRILLATOR

    MDR report key: 2243617 · Received July 27, 2011

    Report

    Report Number
    3015876-2011-00559
    Event Type
    Malfunction
    Date Received
    July 27, 2011
    Date of Event
    July 1, 2011
    Report Date
    July 1, 2011
    Manufacturer
    PHYSIO-CONTROL, INC.
    Product Code
    MKJ
    PMA / PMN Number
    K011144
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PHYSIO-CONTROL EVALUATED THE DEVICE AND VERIFIED THE REPORTED FAILURE. PHYSIO DETERMINED THAT THE CAUSE OF THE REPORTED FAILURE WAS DUE TO A FAILURE OF AN INTEGRATED CIRCUIT CHIP, DESIGNATOR U29 FROM THE DIGITAL PCB ASSEMBLY. THE CUSTOMER WAS PROVIDED WITH A REPLACEMENT DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE DISPLAYED ALL THREE (ATTENTION, CHARGE-PAK AND WRENCH) ICONS AND FAILED TO POWER ON. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFEPAK CR PLUS DEFIBRILLATOR MKJ PHYSIO-CONTROL, INC. CRPLUS NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA