BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURGICAL LIGHTING SYSTEM

    MDR report key: 33205 · Received May 24, 1996

    Report

    Report Number
    MW4001202
    Event Type
    Malfunction
    Date Received
    May 24, 1996
    Report Date
    November 30, 1995
    Manufacturer
    AMERICAN STERILIZER CO.
    Product Code
    FSY
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    RPTR HAD TWO TRACK MOUNTED VERSIONS OF THE SYSTEM THAT HAVE HAD ONGOING PROBLEMS WITH BRUSHES OVERHEATING. THE BRUSHES MAKE CONTACT WITH POWER BY PRESSING AGAINST CONTACT STRIPS IN THE "SIDE EXTRUSIONS," WHICH GO FROM END TO END AND ACT AS A DRESS COVER FOR THE MOUNTING TRACK. THE SIDE EXTRUSIONS ARE MADE FROM FLEXIBLE PLASTIC. THE PLASTIC APPARENTLY WARPS OR BENDS, MOVING THE EXTRUSION AWAY FROM THE BRUSHES. RPTR THEN GETS ARCING FROM THE CONTACT STRIPS TO THE BRUSHES. THIS CAUSES BURN (MELT) SPOTS ON THE SIDE EXTRUSION, AND HEATS THE BRUSHES. WHEN THE BRUSHES BECOME HOT, THE PLASTIC BRUSH HOUSING ALSO OVERHEATS. THE TERMINAL INSERTS ON THE BACK OF THE BRUSH HOUSING (HOT, NEUTRAL AND GROUND CONNECTIONS) NOW SLIP OUT OF THE HOSUING, MOVING THE BRUSHES FARTHER FROM THE CONTACT STRIPS UNTIL THE LAMP LOSES POWER COMPLETELY. CO HAS BEEN ACTIVELY INVOLVED IN REPLACING BRUSH HOUSING ASSEMBLIES, SIDE EXTRUSIONS, AND ADDING SPACERS TO MOVE THE BRUSH HOUSING ASSEMBLIES CLOSER TO THE CONTACTS. ONE UNIT HAS HAD 4 BRUSH ASSEMBLIES AND THREE SIDE EXTRUSIONS REPLACED, AND THE OTHER UNIT HAS HAD 5 BRUSH ASSEMBLIES REPLACED (EACH UNIT CONSISTS OF THREE LAMPS AND BRUSH ASSEMBLIES) IN THE COURSE OF ONE YEAR. CO HAS BEEN ACTIVELY INVOLVED IN REPLACING BRUSH HOUSING ASSEMBLIES, SIDE EXTRUSIONS, AND ADDING SPACERS TO MOVE THE BRUSH HOUSING ASSEMBLIES CLOSER TO THE CONTACTS. ONE UNIT HAS HAD 4 BRUSH ASSEMBLIES REPLACED (EACH UNIT CONSISTS OF THREE LAMPS AND BRUSH ASSEMBLIES) IN THE COURSE OF ONE YEAR. IT IS OBVIOUS THERE IS A BRUSH TO SIDE EXTRUSION CONTACT PROBLEM, AND CO IS LOOKING FOR A RESOLUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SURGICAL LIGHTING SYSTEM SURGICAL LIGHTING SYSTEM FSY AMERICAN STERILIZER CO. OTC-93

    Patients

    Seq Age Sex Outcome Treatment
    1 NA