BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHAMPAINE 5100B OPERATING ROOM TABLE

    MDR report key: 892956 · Received June 29, 2007

    Report

    Report Number
    892956
    Event Type
    Malfunction
    Date Received
    June 29, 2007
    Date of Event
    June 1, 2007
    Report Date
    June 29, 2007
    Manufacturer
    GETINGE USA, INC.
    Product Code
    FQO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NY, US

    Narratives

    Description of Event or Problem · 1

    AS PATIENT WAS BEING TAKEN OFF THE SHAMPAINE 5100B OR TABLE, THE TABLE TILTED 4 INCHES OFF THE FLOOR (NO HARM TO THE PATIENT). THE TABLE WAS CHECKED BY 3 STAFF MEMBERS AND WAS NOTED TO BE IN THE LOCKED POSITION. TWO ADDITIONAL STAFF MEMBERS WERE ABLE TO TILT THE TABLE TO THE SIDE AND RAISE IT FROM THE FLOOR. TABLE HAS BEEN ASSESSED BY CONTRACTED SERVICE PROVIDER. WRITTEN ASSESSMENT WILL BE PROVIDED WHEN PROVIDED TO THE FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SHAMPAINE 5100B OPERATING ROOM TABLE TABLE, SURGICAL FQO GETINGE USA, INC. 5100B *

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR