BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    6702 HERCULES SURGICAL TABLE

    MDR report key: 5130017 · Received October 1, 2015

    Report

    Report Number
    MW5056847
    Event Type
    Malfunction
    Date Received
    October 1, 2015
    Date of Event
    September 9, 2015
    Report Date
    September 23, 2015
    Manufacturer
    SKYRON
    Product Code
    GDC
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    KY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS POSITIONED ON TABLE LATERAL WITH LEFT SIDE DOWN FOR RIGHT SHOULDER SURGERY. WITNESSES IN ROOM STATED TABLE BEGAN RISING DURING PROCEDURE WITHOUT ANYONE TOUCHING CONTROLS. THEN THE TABLE PROCEEDED TO TILT RIGHT, THEN THE BACK FLEXED TO HYPERFLEX THE PATIENT IN THE BEACH CHAIR POSITION. PROCEDURE WAS COMPLETED. PATIENT'S LEFT LEG SLIDE OFF TABLE, SURGEON, ASSISTANT, RESIDENT, AND SCRUB TECH HELD PATIENT TO PREVENT FALLING OFF TABLE. TABLE DID NOT RESPOND TO CONTROLS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    650323 6702 HERCULES SURGICAL TABLE 6702 HERCULES SURGICAL TABLE GDC SKYRON

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR