BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SKYTRON MODEL ELITE 6500

    MDR report key: 1058843 · Received June 6, 2008

    Report

    Report Number
    1058843
    Event Type
    Malfunction
    Date Received
    June 6, 2008
    Date of Event
    February 20, 2008
    Report Date
    March 13, 2008
    Manufacturer
    SKYTRON
    Product Code
    FQO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    DURING AN OPERATION IN THE OR A LOUD SOUND WAS HEARD FROM ALL PERSONNEL. A BLUE FLAME WAS OBSERVED (ABOUT 6 INCHES IN LENGTH) FROM THE ELECTRICAL OUTLET AT THE BASE OF THE TABLE. SMOKE WAS NOTICED COMING FROM THE BOTTOM OF THE STERILE DRAPES PLACED OVER THE PATIENT, WHICH HAD BEGUN TO SMOLDER. THE DRAPES WERE INSTANTLY REMOVED AND STOMPED OUT BY PERSONNEL. THE CORD PLUG HAD MELTED INTO THE ELECTRICAL RECEPTACLE IN TO THE BASE OF THE TABLE WAS FORCIBLY REMOVED. NO HARM OCCURRED TO THE PATIENT.====================== MANUFACTURER RESPONSE FOR ELECTRIC OPERATING ROOM TABLE, SKYTRON MODEL ELITE 6500======================QUALIFIED REPAIR SERVICE HAS INSPECTED AND REPAIRED THE TABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SKYTRON MODEL ELITE 6500 TABLE, SURGICAL FQO SKYTRON 6500NB *

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR OTHER| OTHER