BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SKYTRON IF 30 TV

    MDR report key: 539394 · Received August 16, 2004

    Report

    Report Number
    539394
    Event Type
    Malfunction
    Date Received
    August 16, 2004
    Date of Event
    June 30, 2004
    Report Date
    August 15, 2004
    Manufacturer
    DAI-ICHI SHOMEI CO., LTD
    Product Code
    FSY
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    SKYTRON LIGHT CAUGHT FIRE CAUSING SMOKE TO ISSUE FROM THE "LIGHT HEAD". DEVICE USAGE PROBLEM: DEVICE MALFUNCTION - THAT IS, THE DEVICE DID NOT DO WHAT THEY WERE SUPPOSED TO DO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SKYTRON IF 30 TV SURGICAL LIGHT FSY DAI-ICHI SHOMEI CO., LTD INFINITY NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other