BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MLX 300W XENON LIGHTSOURCE

    MDR report key: 4172250 · Received October 9, 2014

    Report

    Report Number
    1222895-2014-00027
    Event Type
    Malfunction
    Date Received
    October 9, 2014
    Report Date
    September 17, 2014
    Manufacturer
    INTEGRA BURLINGTON, MA. INC.
    Product Code
    FCW
    PMA / PMN Number
    K081477
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION.

    Description of Event or Problem · 1

    A (2 OF 2 PR). TWO MLX LIGHT SOURCES ARE EXPERIENCING PROBLEMS SUCH AS EXCESSIVE HEAT AND FAILURE TO TURN ON. ON (B)(6) 2014, CUSTOMER REPORTS AFTER THE DEVICE WAS IN USE FOR TEN MINUTES, THEY COULD SMELL PLASTIC, NOT A BURNING SMELL. THEY TURNED DEVICE OFF AND IT WOULD NOT IGNITE UNTIL IT COOLED OFF. NO HARM DONE, NO PROCEDURE ISSUES. REPLACEMENT DEVICE READILY AVAILABLE. NO DELAY. DEVICE HAD 200 HOURS. NO SPECIFIC CASE DETAILS AVAILABLE. PREVIOUS RELATED MANUFACTURER'S REPORT NUMBER 1222895-2014-00026.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    636901 MLX 300W XENON LIGHTSOURCE NA FCW INTEGRA BURLINGTON, MA. INC.

    Patients

    Seq Age Sex Outcome Treatment
    1