BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 525576 · Received May 19, 2004

    Report

    Report Number
    525576
    Event Type
    Malfunction
    Date Received
    May 19, 2004
    Date of Event
    January 1, 2004
    Report Date
    February 1, 2004
    Manufacturer
    SKYTRON, (DIVISION OF KMW GROUP)
    Product Code
    FQO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    GA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WHEN THE TABLE WAS BEING RAISED, THE TABLE TOP BEGAN TO TILT ON ITS OWN AND COULD ONLY BE STOPPED BY REMOVING POWER TO THE TABLE. IT WAS FOUND THAT THE WIRES CONNECTING THE RELAY CONTROLLER TO THE MICROSWITCH HAD BEEN CUT, EXPOSING WIRES. WHEN THE TABLE WAS RAISED, THE BARE WIRE WOULD SHORT ON TABLE CHASSIS CAUSING THE TABLE TO BEGIN TILTING. HOSP STAFF CONTACTED THE SERVICE MANAGER FOR A SKYTRON DEALER. HE INDICATED THAT SOME OF THESE UNITS WERE SHIPPED FROM THE FACTORY WITHOUT THE RELAY CONTROLLER CABLE PROPERLY SECURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * SURGICAL TABLE FQO SKYTRON, (DIVISION OF KMW GROUP) 3500 *

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR