BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PICKER CLINIX PLUS

    MDR report key: 2100952 · Received May 20, 2011

    Report

    Report Number
    2100952
    Event Type
    Malfunction
    Date Received
    May 20, 2011
    Date of Event
    March 10, 2010
    Report Date
    September 30, 2010
    Manufacturer
    PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    POOR IMAGE QUALITY. REQUIRED OBTAINING IMAGE ADJUSTMENT SOFTWARE. INFORMED BY PHILIPS/PICKER THAT EQUIPMENT IS AT ITS END OF LIFE AND THEREFORE THE IMAGE ADJUSTMENT SOFTWARE WAS NOT AVAILABLE. UNABLE TO IMPROVE IMAGE AT THIS TIME. PLAN FOR REPLACEMENT OF EQUIPMENT

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PICKER CLINIX PLUS SYSTEM, X-RAY, RAD/FLUORO JAA PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC. CLINIX PLUS (R&F) *

    Patients

    Seq Age Sex Outcome Treatment
    1 *