BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTIDIAGNOST ELEVA

    MDR report key: 2013717 · Received February 3, 2011

    Report

    Report Number
    3003768277-2011-00119
    Event Type
    Malfunction
    Date Received
    February 3, 2011
    Report Date
    January 6, 2011
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    KPR
    PMA / PMN Number
    K031535
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE INVESTIGATION IS STILL ONGOING ON THIS EVENT. WHEN THE INVESTIGATION IS COMPLETED, A F/U REPORT WILL BE SENT TO THE FDA BY (B)(4) 2011.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SYSTEM WILL STOP MAKING X-RAYS IN MIDDLE OF A CASE AND DISPLAY AN IITV (IMAGE INTENSIFIER CAMERA) ERROR ON THE EEC. THIS PROBLEM OCCURS A FEW TIMES A WEEK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MULTIDIAGNOST ELEVA KPR, IXL, IXR, JAA KPR PHILIPS HEALTHCARE 708032

    Patients

    Seq Age Sex Outcome Treatment
    1