BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUT EXT DR FINAL ASSY-REVERSE

    MDR report key: 1243091 · Received November 21, 2008

    Report

    Report Number
    1518293-2008-00362
    Event Type
    Malfunction
    Date Received
    November 21, 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
    RI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    LIEBEL FLARSHEIM MANUFACTURING REPORT: FIELD SERVICE ENGINEER TROUBLESHOT PROBLEM OF NO LATERAL MOVEMENT, AND LUBRICATED THE LATERAL BEARING ASSEMBLY. FSE VERIFIED PROPER OPERATION PER HUT SERVICE MANUAL FLAT PANEL CONFIGURATION AND PARTS MANUAL. UNIT RETURNED TO FULL SERVICE BY THE CUSTOMER.

    Description of Event or Problem · 1

    CUSTOMER REPORTS THAT DURING A RETROGRADE TYPE PROCEDURE WITH A VERY LARGE PATIENT, THE TABLE WOULD NOT MOVE AT ALL. CUSTOMER UNWILLING TO PROVIDE PATIENT'S INFORMATION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK