BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUT EXT DR FINAL ASSY-REVERSE

    MDR report key: 1032307 · Received April 22, 2008

    Report

    Report Number
    1518293-2008-00165
    Event Type
    Malfunction
    Date Received
    April 22, 2008
    Date of Event
    March 24, 2008
    Report Date
    March 24, 2008
    Manufacturer
    LIEBEL-FLARSHEIM CO.
    Product Code
    KQS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    LIEBEL FLARSHEIM FIELD SERVICE ENGINEER SERVICE REPORT. FSE REPLACED GIM BOX CONTROL AND RELOADED SOFTWARE AND VERIFIED OPERATION TO MANUFACTURED SPECIFICATIONS AND RETURNED TO SERVICE.

    Description of Event or Problem · 1

    CUSTOMER REPORTED IN 2008, THAT DURING A UTEROPLASTY PROCEDURE ON A FEMALE THAT THE FLUORO STOPPED WORKING AND THE PATIENT NEEDED TO BE TRANSFERRED TO ANOTHER UROLOGY ROOM TO HAVE THE PROCEDURE COMPLETED. SHE REPORTED THAT THERE WERE NO INJURIES OR COMPLICATIONS DUE TO THE MALFUNCTION OF THE FLUORO NOT WORKING.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR