BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUT EXT DR FINAL ASSY,RE,FPD

    MDR report key: 6640568 · Received June 14, 2017

    Report

    Report Number
    1518293-2017-00018
    Event Type
    Malfunction
    Date Received
    June 14, 2017
    Date of Event
    May 17, 2017
    Report Date
    June 14, 2017
    Manufacturer
    LIEBEL-FLARSHEIM
    Product Code
    MQB
    PMA / PMN Number
    K121838
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    RADIOLOGIC TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    NOT IMAGING AT ALL. TECH UNABLE TO PRODUCE IMAGES, FLUORO OR RAD. MULTIPLE SYSTEM REBOOTS AND GIM RESETS BUT STILL UNABLE TO PRODUCE IMAGE. POWERED SYSTEM OFF AND LEFT UNTIL SERVICE ARRIVES, WHEN SYSTEM STARTED IT WORKS. FOLLOW UP INFORMATION: "AFTER THE SYSTEM FAILED THERE WAS NO FLUORO OR RAD. THERE WAS FLUORO AND RAD WHEN THEY STARTED THE CASE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    420108 HUT EXT DR FINAL ASSY,RE,FPD HUT EXT DR FINAL ASSY,RE,FPD MQB LIEBEL-FLARSHEIM 414007

    Patients

    Seq Age Sex Outcome Treatment
    1