BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK CR PLUS DEFIBRILLATOR

    MDR report key: 1070568 · Received July 2, 2008

    Report

    Report Number
    3015876-2008-00734
    Event Type
    Malfunction
    Date Received
    July 2, 2008
    Date of Event
    June 4, 2008
    Report Date
    June 4, 2008
    Manufacturer
    PHYSIO-CONTROL, INC.
    Product Code
    MKJ
    PMA / PMN Number
    K011144
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS BEING RETURNED TO PHYSIO-CONTROL FOR EVAL.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE DEVICE SHOWED THE CHARGE PACK AND ATTENTION WARNING ICONS. IT WAS ALSO REPORTED THAT THE DEVICE WILL NOT TURN ON. THE REPORTED PROBLEM WAS FOUND DURING ROUTINE TESTING OF THE DEVICE.

    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