BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUT EXT DR FINAL ASSY-STANDARD

    MDR report key: 4661417 · Received April 6, 2015

    Report

    Report Number
    1518293-2015-00017
    Event Type
    Malfunction
    Date Received
    April 6, 2015
    Date of Event
    March 19, 2015
    Report Date
    March 19, 2015
    Manufacturer
    LIEBEL FLARSHEIM
    Product Code
    IXR
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    TECH SERVICE INITIALLY TROUBLESHOT WITH A RAD TECH WHO REPORTED A COMPUTER PROBLEM (PLATINUM ONE) WHERE NO LIVE FLUORO IMAGE OR LAST IMAGE HOLD (LIH) COULD BE SEEN IN THE ACQUIRE MODE. TECH SERVICE CONFIRMED THAT SYSTEM WAS FLUOROING AND PRODUCING IMAGES, AND FOUND THAT THE `COLORS' SELECTION IN WINDOWS DISPLAY PROPERTIES HAD BEEN SET INCORRECTLY. TECH SERVICE HAD THE RAD TECH RE-SET IT TO `TRUE COLOR 32 BIT' AND WHEN SHE RETURNED TO APPLICATION, THE LIVE FLUORO IMAGES AND LIH WAS SEEN ON ALL MONITORS AS NORMAL. IT WAS UNKNOWN HOW THE WINDOWS SETTING WAS CHANGED. THE UNIT WAS FULLY FUNCTIONAL. THE CUSTOMER CALLED BACK THE SAME DAY SAYING THEY STILL HAD A COMPUTER ISSUE AND WOULD LIKE A FIELD SERVICE ENGINEER (FSE) TO VISIT. THE FSE INVESTIGATED THE REPORT THAT INTERMITTENTLY THE INFIRMED LOCKED UP AND THEY HAD TO DO A HARD SHUTDOWN OF THE SYSTEM. FSE CHECKED THE COMPUTER SYSTEM FOR PROPER AIR FLOW, CLEANED FILTERS AND CHECKED CONNECTIONS. BUT WAS UNABLE TO DUPLICATE ANY PROBLEM. PER TECH SERVICE IT WAS DECIDED TO BYPASS THE UNINTERRUPTIBLE POWER SUPPLY (UPS) AND PLUG SYSTEM INTO WALL POWER TO MAKE SURE THE UPS WAS NOT CAUSING PROBLEM. FSE FOLLOWED UP WITH THE CUSTOMER A FEW DAYS LATER, AND WAS TOLD THE PROBLEM HAD NOT RECURRED. THEY BELIEVE THE PROBLEM WAS THE FACILITIES UPS AND THE UNIT IS NOW IN FULL SERVICE.

    Description of Event or Problem · 1

    CUSTOMER STATES DURING A CYSTOGRAM WITH BILATERAL RETROGRADE STENT PLACEMENT THE FLUORO FAILED (THEY WERE UNABLE TO SEE IMAGES ON THE MONITOR). THE PATIENT WAS MOVED TO ANOTHER ROOM AND A C-ARM WAS USED TO COMPLETE THE PROCEDURE. NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    225132 HUT EXT DR FINAL ASSY-STANDARD HUT EXT DR IXR LIEBEL FLARSHEIM HUT

    Patients

    Seq Age Sex Outcome Treatment
    1