BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHAMPAINE OPERATING ROOM TABLE

    MDR report key: 2003614 · Received February 18, 2011

    Report

    Report Number
    MW5019545
    Event Type
    Injury
    Date Received
    February 18, 2011
    Date of Event
    February 2, 2011
    Report Date
    February 18, 2011
    Manufacturer
    GETINGE - CASTLE USA, INC
    Product Code
    FQO
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THIS OPERATING ROOM TABLE WAS IN USE WITH AN OBSTETRICS PT. THE PT WAS BEING PREPARED FOR A CESAREAN SECTION, TO BE PERFORMED UNDER SPINAL ANESTHESIA. THE PT WAS BROUGHT TO THE OB OPERATING ROOM AND WAS POSITIONED ON THE OPERATING ROOM TABLE FOR THE INTRODUCTION OF THE SPINAL ANESTHESIA. THE TABLE DID NOT SUPPORT THE WEIGHT OF THE PT. THE HEAD PART OF THE TABLE WENT DOWN CAUSING A HIGH SPINAL TO BE ADMINISTERED. ON REVIEW: THE O.B. OPERATING ROOM TABLE WAS REMOVED AND SENT TO THE DISTRIBUTOR FOR REPAIR. AN ALTERNATE MODEL WAS DELIVERED AND IS IN USE WITHOUT INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SHAMPAINE OPERATING ROOM TABLE NONE FQO GETINGE - CASTLE USA, INC 5100B

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Disability