BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SKYTRON

    MDR report key: 893497 · Received August 7, 2007

    Report

    Report Number
    1825014-2007-00008
    Event Type
    Malfunction
    Date Received
    August 7, 2007
    Date of Event
    July 19, 2007
    Report Date
    July 25, 2007
    Manufacturer
    THE KMW GROUP, SKYTRON DIVISION
    Product Code
    BWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE TABLE WAS EXAMINED IN 2007. UPON INSPECTION, IT WAS IMMEDIATELY NOTICEABLE THAT THERE WAS DAMAGE TO THE LOW VOLTAGE (24 VOLT) CIRCUIT CONDUCTORS. THESE CONDUCTORS CAN BE FOUND NEAR THE ELECTRICAL CONNECTOR THAT PLUGS INTO THE TABLES RELAY BOX ASSEMBLY. THE EXTERIOR INSULATION OF THE CONDUCTORS EXHIBITED SIGNS OF DAMAGE FROM HEAT (SLIGHTLY MELTED). ADDITIONAL INVESTIGATION REVEALED THAT THE CAUSE OF THE FAILURE WAS A SHORT TO GROUND. IT IS APPARENT ON THE RED (+24 VOLT) CONDUCTOR THAT IT WAS PINCHED AGAINST A METAL BRACKET CREATING A RESISTANT POINT. THIS IS EVIDENT BECAUSE THE IMPRINT OF THE METAL BRACKET IS SHAPED INTO THE OUTER JACKET OF THE CONDUCTOR. DAMAGE TO THE RELAY BOX CONTROL CIRCUIT RESULTED FROM THE SHORT WHICH MADE THE TABLE INOPERABLE. IT APPEARS THAT THE LAST INDIVIDUAL WHO SERVICED THE TABLE OR REMOVED THE ACCESS COVER DID NOT EXERCISE CARE TO ROUTE THE WIRE HARNESS CORRECTLY AND CREATED A PINCH POINT.

    Description of Event or Problem · 1

    PT WAS ON A SKYTRON 3600B TABLE WHEN IT STARTED TO SMELL LIKE SMOKE. THE PT WAS ANESTHETIZED AND WAS MOVED TO ANOTHER TABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SKYTRON SURGICAL TABLE BWN THE KMW GROUP, SKYTRON DIVISION 3600B

    Patients

    Seq Age Sex Outcome Treatment
    1 YR