BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OVERHEAD EXAMINATION LIGHT

    MDR report key: 31401 · Received March 20, 1996

    Report

    Report Number
    MW4001125
    Event Type
    Malfunction
    Date Received
    March 20, 1996
    Date of Event
    November 26, 1995
    Report Date
    December 11, 1995
    Manufacturer
    MEDICAL ILLUMINATION, INC.
    Product Code
    FSY
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MT, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ON 11/26/95 STAFF MEMBER WAS IN EXAM ROOM TO HELP WITH A PROCEDURE. THE STAFF MEMBER TURNED ON THE CEILING MOUNTED SPOTLIGHT AND THE DR SAID IT WAS NOT NEEDED SO THE STAFF MEMBER TURNED OFF THE LIGHT, RAISED THE LAMP TO PREVENT THE DOCOR FROM HITTING HIS HEAD. THE LIGHT BULB BLINKED A COUPLE OF TIMES EVEN WITH THE SWITCH OFF AND THEN SPARKS AND SMOKE CAME OUT FROM AROUND THE SWITCH AREA FOR A VERY BRIEF MOMENT. THE LIGHT WAS NOT TOUCHED AGAIN AND MEDICAL MAINTENANCE WAS NOTIFIED. NO HARM OR SHOCKS OCCURRED TO THE PT OR THE MEDICAL STAFF. RPTR WAS NOTIFIED OF AN OVERHEAD EXAMINATION LIGHT THAT WAS SMOKING AND SHOOTING SPARKS. AFTER NECESSARY SAFETY MEASURES WERE TAKEN, THE LIGHT ARM AND HEAD WERE DISASSEMBLED AND THE CAUSE WAS IDENTIFIED. AT THE LOWER SECTION OF THE ARM, THE HOT WIRE HAD BEEN STRETCHED TO THE POINT OF BREAKING. THIS EXPOSED THE 120V LINE DIRECTLY TO THE METAL CASING CAUSING SPARKS AND A POTENTIALLY LIFE THREATENING SITUATION. THE UNIT WAS REMOVED FROM SERVICE. FOUR OTHER UNITS IN THE BUILDING HAVE HAD SIMILAR PROBLEMS WITH THE EXAM LIGHTS' INTENDED STOP MECHANISM NOT FUNCTIONING PROPELRY. THIS ALLOWS THE POWER CORD TO WRAP ITSELF AROUND THE BASE OF THE LIGHT, EVENTUALLY PULLING THE WIRES APART. RPTR CONTACTED THE MFR WHO SAID THEY HAVE MADE THIS SYSTEM ABOUT 17 YEARS. THE COMPLAINANTS' LIGHT IS ABOUT 6 YEARS OLD. THEY REPORTED THAT THEY HAVE HAD NO SIMILAR COMPLAINTS BUT ARE INVESTIGATING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OVERHEAD EXAMINATION LIGHT OVERHEAD EXAMINATION LIGHT FSY MEDICAL ILLUMINATION, INC. 11314-6

    Patients

    Seq Age Sex Outcome Treatment
    1 *