BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BV LIBRA 9" SURVEY

    MDR report key: 2211941 · Received August 10, 2011

    Report

    Report Number
    3003768277-2011-00487
    Event Type
    Malfunction
    Date Received
    August 10, 2011
    Report Date
    July 15, 2011
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    IZL
    PMA / PMN Number
    K010762
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). WHEN INVESTIGATION IS COMPLETED A FOLLOW-UP REPORT WILL BE SENT TO THE FDA.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED AN INTERMITTENT IMAGE PROBLEM AND WHEN THE SYSTEM IS USED DURING HIGH DOSE FLUOROSCOPY, IT STOPS RESPONDING AFTER INITIAL FLUOROSCOPY COMMAND. THERE IS AN ERROR MESSAGE ON SCREEN "PLEASE REBOOT SYSTEM".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BV LIBRA 9" SURVEY IZL PHILIPS HEALTHCARE 718030

    Patients

    Seq Age Sex Outcome Treatment
    1