BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELITE

    MDR report key: 18031 · Received November 29, 1994

    Report

    Report Number
    MW1004180
    Event Type
    Injury
    Date Received
    November 29, 1994
    Date of Event
    November 7, 1994
    Report Date
    November 17, 1994
    Manufacturer
    SKYTRON DIV. OF THE KMW
    Product Code
    FQO
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    LA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    WHILE DOING LAPAROSCOPIC CHOLECYSTECTOMY ON PT WEIGHING IN EXCESS OF 350 LBS, THE OR TABLE WOULD POSITION FROM SIDE TO SIDE AND DOWN OK, BUT HEIGHT OF TABLE COULD NOT BE CHANGED. IF THE BED WAS PUT DOWN, COULD NOT GET IT BACK UP AGAIN. MOTOR COULD BE HEARD RUNNING, BUT WAS NOT STRONG ENOUGH TO LIFT THE OBESE PT. THE ATTACHED TABLE INFO WAS CHECKED PRIOR TO CASE AND INFO STATED CLEARLY THAT BED COULD "LIFT UP AND FULLY ARTICULATE A 500 LB PT". THIS SITUATION MADE AN ALREADY DIFFICULT CASE MORE DIFFICULT. (TWO MALE NURSES) TRIED TO WORK OR TABLE CONTROLS FOR SURGEON DURING CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ELITE SURGICAL TABLE FQO SKYTRON DIV. OF THE KMW 6500 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Life Threatening| O