BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONY LC SURGICAL LIGHT

    MDR report key: 1051958 · Received May 22, 2008

    Report

    Report Number
    1043572-2008-00013
    Event Type
    Malfunction
    Date Received
    May 22, 2008
    Date of Event
    April 29, 2008
    Report Date
    May 22, 2008
    Manufacturer
    STERIS CORPORATION - MONTGOMERY
    Product Code
    FTD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    STERIS TECHNICIAN WAS DISPATCHED TO THE ACCOUNT. AFTER INSPECTION OF THE LIGHT HEAD, THE TECH REPLACED THE DEFECTIVE LIGHTHEAD AND IS RETURNING IT TO THE FACTORY FOR EVALUATION. THE PRODUCT IS UNDER WARRANTY. TECHNICIAN'S FINDINGS: PC BOARD AND PCB TO LAMP HARNESS-LC WERE CHARRED AND BLACKENED. SMOKE DAMAGE OCCURRED INTERNALLY TO THE LIGHTHEAD LENSES AND FRAMEWORK. NO INJURY WAS REPORTED. NO INDICATION OF ANY OPEN FLAMES OR FIRE. THE LIGHT HEAD WAS TURNED OFF TO STOP THE SMOKING. AS OF THE DATE OF THIS REPORT THE SUSPECT ITEM HAS NOT BEEN RECEIVED FOR EVALUATION, STERIS CORPORATION WILL SUBMIT A FOLLOW-UP REPORT TO FDA ONCE THE ITEM HAS BEEN RETURNED AND EVALUATED AS TO THE ROOT CAUSE OF THE MALFUNCTION.

    Description of Event or Problem · 1

    HARMONY LC HAD CHARRED PCB TO LAMP HARNESS-LC PART # P14667008 AND CHARRED LC LH BOARD WITH OUT CAMERA PART #P146670008.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HARMONY LC SURGICAL LIGHT SURGICAL LAMP FTD STERIS CORPORATION - MONTGOMERY 2012471 NA

    Patients

    Seq Age Sex Outcome Treatment
    1