BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUT EXT DR FINAL ASSY-STANDARD

    MDR report key: 1211883 · Received October 23, 2008

    Report

    Report Number
    1518293-2008-00311
    Event Type
    Malfunction
    Date Received
    October 23, 2008
    Date of Event
    September 24, 2008
    Report Date
    September 24, 2008
    Manufacturer
    LIEBEL-FLARSHEIM CO.
    Product Code
    KQS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    LIEBEL FLARSHEIM MANUFACTURING REPORT: FIELD SERVICE ENGINEER TROUBLESHOT THE SYSTEM AND FOUND THAT THE INTEGRATED CONSOLE WOULD NOT BOOT UP, AND REPLACED IT WITH A NEW INTEGRATED CONSOLE. FSE VERIFIED SYSTEM OPERATION USING SERVICE MANUAL PN 710953, AND HUT INSTALLATION, AND SERVICE MANUAL PN 4041004. UNIT RETURNED TO FULL SERVICE BY THE CUSTOMER.

    Description of Event or Problem · 1

    CUSTOMER OR NURSE REPORTS DURING A RETROGRADE CYSTOGRAM PROCEDURE ON A MALE, THEY STARTED TO HAVE PROBLEMS WITH THE FLUORO INTERMITTENTLY SHUTTING OFF DURING THE PROCEDURE. THE FLUORO FINALLY STOPPED WORKING, AND THEY BROUGHT IN ANOTHER TABLE AND C-ARM TO COMPLETE THE PROCEDURE. CUSTOMER REPORTED NO INJURIES TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HUT EXT DR FINAL ASSY-STANDARD UROLOGY SUITE KQS LIEBEL-FLARSHEIM CO. HUT EXT DR NA

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR