BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUT EXT DR FINAL ASSY-STANDARD

    MDR report key: 1032306 · Received April 22, 2008

    Report

    Report Number
    1518293-2008-00161
    Event Type
    Malfunction
    Date Received
    April 22, 2008
    Date of Event
    March 26, 2008
    Report Date
    March 26, 2008
    Manufacturer
    LIEBEL-FLARSHEIM CO.
    Product Code
    KQS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    LIEBEL FLARSHEIM SERVICE REPORT, FIELD SERVICE ENGINEER FOUND THE TABLE TOP NOT SECURED TO HINGE. THE BONDING MATERIAL DID NOT HOLD. FSE REPLACED THE TABLETOP.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT WHILE SLIDING A HEAVY PATIENT ONTO THE UROLOGY TABLE, THEY NOTICED THE VENEER ON THE TABLE TOP SHIFTED WITH THE PATIENT. HE ALSO REPORTED THE HINGE TO THE TABLE TOP WAS LOOSE. HE REPORTED THAT THEY WERE ABLE TO SLIDE THE PATIENT BACK ONTO THE STRETCHER WITHOUT ANY INCIDENT. PATIENT WAS TRANSFERRED TO ANOTHER PROCEDURE ROOM.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR