BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHAMPAINE

    MDR report key: 474414 · Received July 25, 2003

    Report

    Report Number
    3019090-2003-00002
    Event Type
    Malfunction
    Date Received
    July 25, 2003
    Date of Event
    June 23, 2003
    Report Date
    June 28, 2003
    Manufacturer
    GETINGE USA, INC
    Product Code
    FQO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING A SURGICAL PROCEDURE, THE TABLE TOP STARTED TO MOVE INTO REVERSE TRENDELENBURG WITHOUT BEING ACTIVATED TO MOVE INTO THIS POSITION BY O.R. PERSONNEL. THE MOVEMENT WAS STOPPED BY REMOVING THE HAND CONTROL FROM THE TABLE. THE PT WAS REPOSITIONED USING THE AUXILIARY HAND CONTROL. NO INJURIES TO THE PT OR O.R. PERSONNEL RESULTED FROM THIS INCIDENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Other