BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUTIV FINAL ASSY, REV, RIGHT

    MDR report key: 1334642 · Received February 24, 2009

    Report

    Report Number
    1518293-2009-00034
    Event Type
    Malfunction
    Date Received
    February 24, 2009
    Date of Event
    January 30, 2009
    Report Date
    January 30, 2009
    Manufacturer
    LIEBEL-FLARSHEIM CO.
    Product Code
    KQS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FIELD SERVICE ENGINEER FOUND THE FLUORO KV PRESET LOCKED IN AT 50 KV ON THE GENERATOR CONTROL PANEL. IT WAS NOT IN THE AUTOMATIC EXPOSURE MODE WANTED BY THE USER. FSE UNLOCKED THE SET POINT, RETURNED IT TO THE AUTOMATIC EXPOSURE MODE AND THE SYSTEM FUNCTIONED PER CUSTOMERS INTENT. SYSTEM RETURNED TO FULL SERVICE BY THE CUSTOMER.

    Description of Event or Problem · 1

    CUSTOMER REPORTS THAT DURING A STENT PLACEMENT ON A MALE, THE FLUORO STOPPED WORKING. THE PATIENT HAD TO BE MOVED TO ANOTHER ROOM FOR THE PROCEDURE TO BE COMPLETED. NO REPORT OF INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HUTIV FINAL ASSY, REV, RIGHT UROLOGY SUITES KQS LIEBEL-FLARSHEIM CO. HUTIV NA

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR