BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUTIV FINAL ASSY, REV, RIGHT

    MDR report key: 2121707 · Received May 19, 2011

    Report

    Report Number
    1518293-2011-00096
    Event Type
    Malfunction
    Date Received
    May 19, 2011
    Date of Event
    May 10, 2011
    Report Date
    May 10, 2011
    Manufacturer
    LIEBEL-FLARSHEIM CO.
    Product Code
    KQS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FIELD SERVICE ENGINEER TROUBLESHOOT REPORTED TABLE MOVEMENT PROBLEM AND CONFIRMED THAT THE TABLE WOULD ONLY MOVE IN ONE DIRECTION. THERE WERE ALSO SIGNIFICANT OTHER PROBLEMS TO THE EXTENT THAT THE FSE TOLD THE CUSTOMER THIS TABLE, MFG IN 1993, WAS BEYOND REASONABLE REPAIR AND AT END OF LIFE AND THE TABLE SHOULD HAVE NO FURTHER PT USE. FOLLOW UP CALL TO CUSTOMER BY PRODUCT MONITORING; THE CUSTOMER CONFIRMED THEY WERE NOT NOW USING THE TABLE FOR PTS.

    Description of Event or Problem · 1

    ON (B)(6): STAFF REPORTS THAT DURING A RETROGRADE CYSTOGRAM, THE TABLE MOVEMENT FAILED. STAFF MOVED THE PT INTO ANOTHER ROOM AND THE PROCEDURE WAS COMPLETED WITHOUT FURTHER INCIDENT. STAFF DID NOT PROVIDE THE PT GENDER AND AGE. NO REPORTED INJURY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK