BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    X8000 LIGHTSOURCE

    MDR report key: 2050040 · Received March 14, 2011

    Report

    Report Number
    2936485-2011-00151
    Event Type
    Malfunction
    Date Received
    March 14, 2011
    Date of Event
    March 1, 2011
    Report Date
    March 1, 2011
    Manufacturer
    STRYKER ENDOSCOPY SAN JOSE
    Product Code
    FCW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WILL BE PROVIDED ONCE THE INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER A FEW MINUTES INTO THE CASE, THE UNIT STARTED TO SMOKE AND SET OFF THE FIRE ALARM. IT WAS FURTHER REPORTED THAT THE UNIT WAS RUSHED OUT OF THE ROOM AFTER TURNING IT OFF AND UNPLUGGING IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 X8000 LIGHTSOURCE LIGHTSOURCE FCW STRYKER ENDOSCOPY SAN JOSE

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK