BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUT EXT DR FINAL ASSY-REVERSE

    MDR report key: 7398815 · Received April 5, 2018

    Report

    Report Number
    1518293-2018-00009
    Event Type
    Malfunction
    Date Received
    April 5, 2018
    Date of Event
    March 8, 2018
    Report Date
    March 8, 2018
    Manufacturer
    LIEBEL-FLARSHEIM
    Product Code
    IXR
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    RADIOLOGIC TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    NO FLUORO AFTER SOFTWARE UPGRADE. AFTER MANDATORY SEDECAL INTEGRATED CONSOLE FLASH CARD UPGRADE, THE FLUORO IS NOT WORKING INTERMITTENTLY THE DEFAULT CONFIGURATION STEP WAS NOT PERFORMED AND SO THE SEDECAL WAS IN RAD ONLY MODE INSTEAD OF R/F. EVEN AFTER PERFORMING THIS STEP, THE SYSTEM STILL WILL NOT FLUORO. CYCLE POWER ON THE GIM BOX TO NO AVAIL. NOTHING WRONG UPON CHECKING THE SERVICE MODE AT THE GENERATOR INTERFACE SETTINGS. NO INTERLOCKS INDICATED AT THE TABLE OR SEDECAL. ROTOR DOES KICK ON, BUT NO FLUORO IS PRODUCED. PATIENT WAS MOVED TO ANOTHER ROOM TO FINISH. NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    244104 HUT EXT DR FINAL ASSY-REVERSE HUT EXT DR FINAL ASSY-REVERSE IXR LIEBEL-FLARSHEIM 404007

    Patients

    Seq Age Sex Outcome Treatment
    1