BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUT EXT DR FINAL ASSY-REVERSE

    MDR report key: 5018869 · Received August 20, 2015

    Report

    Report Number
    1518293-2015-00079
    Event Type
    Malfunction
    Date Received
    August 20, 2015
    Date of Event
    July 31, 2015
    Report Date
    July 31, 2015
    Manufacturer
    LIEBEL FLARSHEIM
    Product Code
    IXR
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    RADIOLOGIC TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    TECH SUPPORT SPOKE WITH THE CUSTOMER WHO SAID THE OPERATORS COULD NOT GET THE INFIMED I5 TO OPERATE AND HAD TO MOVE THE PATIENT TO A C-ARM TO COMPLETE THE CASE. THE INFIMED WAS DISPLAYING THE MESSAGE - GIM COMMUNICATIONS FAILURE AND THE KEYBOARD/MOUSE WAS LOCKED UP. TECH SERVICE HAD OPERATOR CYCLE THE POWER TO THE GIM BOX BY PHYSICALLY UNPLUGGING/PLUGGING IT BACK IN AND THEN CYCLING POWER ON THE I5 TOWER. ON POWER UP, EVERYTHING WAS NOW WITHOUT ISSUE AND OPERATOR WAS ABLE TO OPEN UP A PATIENT AND PERFORM X-RAY. ALL OF THIS INDICATES THAT THE ORIGINAL ISSUE WAS MOST LIKELY A GIM BOX COMMUNICATIONS ISSUE AND THIS ISSUE WAS CORRECTED BY CYCLING POWER AT THE GIM. THERE ARE CURRENTLY NO OTHER REPORTED ISSUES WITH THIS SYSTEM.

    Description of Event or Problem · 1

    CUSTOMER REPORTS THE FLUORO FAILED DURING A STENT PLACEMENT WITH A GIM COMMUNICATION ERROR. THE PATIENT WAS TRANSFERRED TO ANOTHER ROOM AND THE PROCEDURE WAS COMPLETED WITH A C-ARM. NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    552204 HUT EXT DR FINAL ASSY-REVERSE HUT EXT DR FINAL ASSY-REVERSE IXR LIEBEL FLARSHEIM HUT EXT DR FINAL ASSY-REVERSE

    Patients

    Seq Age Sex Outcome Treatment
    1