BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRALITE PRO HEADLIGHT W/PREMIUM CABLE

    MDR report key: 6720082 · Received July 17, 2017

    Report

    Report Number
    2523190-2017-00080
    Event Type
    Malfunction
    Date Received
    July 17, 2017
    Report Date
    June 20, 2017
    Manufacturer
    INTEGRA YORK, PA INC.
    Product Code
    FCW
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    ON "7/18/19" INTEGRA INVESTIGATION COMPLETED. METHOD: FAILURE ANALYSIS, DEVICE HISTORY EVALUATION. RESULTS: FAILURE ANALYSIS - PICTURES SHOW THIS IS NOT AN INTEGRA PRODUCT. DEVICE HISTORY EVALUATION - PICTURES SHOW THIS IS NOT AN INTEGRA PRODUCT. CONCLUSION: PICTURES SHOW THIS IS NOT AN INTEGRA PRODUCT.

    Additional Manufacturer Narrative · 1

    ON 7/6/2017 INTEGRA TECHNICAL SUPPORT EXAMINED PHOTOS FOR THIS COMPLAINT AND IT APPEARS THAT AN ACULUX (HTTP://ACULUX.NET/) WITH THEIR SURGILUX¿ MODULE (BLUE) IS ATTACHED TO THE INTEGRA AX2100BIF ULTRALITE PRO HEADLIGHT W/PREMIUM CABLE INSTEAD OF INTEGRA HEADLIGHT.. 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

    CUSTOMER INITIALLY REPORTED A 00MLX, SERIAL NUMBER (B)(4), AS THE LIGHT SOURCE WITH ORIGINAL PROBLEM DESCRIBED AS THE LIGHT SOURCE SMOKED AND THE DR. HAD INHALED THE SMOKE. AFTER BIOMED INVESTIGATED THE HEADLIGHT WAS THE REAL SOURCE OF THE EVENT. THE ELBOW RIGHT BEFORE THE BLUE HEADLIGHT HAD MELTED AND THE STAFF IN THE OPERATING ROOM SAID IT CAUSED THE DR'S HEAD COVER TO CATCH FIRE/SMOKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    499287 ULTRALITE PRO HEADLIGHT W/PREMIUM CABLE IMIG FCW INTEGRA YORK, PA INC.

    Patients

    Seq Age Sex Outcome Treatment
    1