BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUTIV TABLE ASSY STD W/COLOR

    MDR report key: 1250820 · Received December 2, 2008

    Report

    Report Number
    1518293-2008-00363
    Event Type
    Malfunction
    Date Received
    December 2, 2008
    Date of Event
    November 4, 2008
    Report Date
    November 4, 2008
    Manufacturer
    LIEBEL-FLARSHEIM CO.
    Product Code
    KQS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER TROUBLESHOT SYSTEM AND FOUND THAT THE ROTOR (STARTER FOR THE X-RAY TUBE) WAS ON, BUT NOT SWITCHING FROM BOOST TO RUN. THE PROBLEM WAS TRACED TO THE CPU. FSE REPLACED THE CPU, BUT CALIBRATION FAILED. FSE THEN DISCOVERED THE HOSPITAL BIOMED HAD CHANGED OUT THE ORIGINAL X-RAY TUBE USING AN AFTERMARKET MODEL. THE FSE PUT THE ORIGINAL X-RAY TUBE BACK ON AND WAS ABLE TO CALIBRATE THE SYSTEM. FSE ALIGNED THE TUBE, SET THE FLUORO DOSE AND PROGRAMMED THE NEW CPU BOARD PER CP60 INSTALLATION AND SERVICE MANUAL. SYSTEM RETURNED TO FULL SERVICE BY THE CUSTOMER.

    Description of Event or Problem · 1

    CUSTOMER REPORTS DURING A PROCEDURE, THE SYSTEM WOULD NOT FLUORO OR PROVIDE DIGITAL SPOT CAPABILITY. PATIENT WAS MOVED TO ANOTHER ROOM FOR COMPLETION OF THE PROCEDURE. AT ABOUT ONE WEEK LATER, CUSTOMER REPORTS A FEMALE HAVING A CYSTOGRAM PROCEDURE WITH STENT PLACEMENT UNDER GENERAL ANESTHESIA. DURING THE PROCEDURE, THE ROOM FAILED AND PT WAS MOVED TO ANOTHER ROOM WHERE THE PROCEDURE WAS COMPLETED WITH NO FURTHER INCIDENT. PT IS DOING FINE, NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HUTIV TABLE ASSY STD W/COLOR UROLOGY SUITE KQS LIEBEL-FLARSHEIM CO. HUT IV NA

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR