BEUDAMED
    FDA Adverse Event Summary report: N

    OVERHEAD EXAMINATION LIGTH

    MDR report key: 38038 · Received September 16, 1996

    Report

    Report Number
    MW4001494
    Date Received
    September 16, 1996
    Report Date
    November 28, 1995
    Manufacturer
    MEDICAL ILLUMINATION, INC.
    Product Code
    FSY
    Report Source
    Voluntary report
    Reporter Location
    MT, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ON 11/26/95 AT APPROX 1600 HRS 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 120 VAC LINE DIRECTLY TO THE METAL CASING CAUSING SPARKS AND A POTENTIALLY LIFE THREATENING SITUATION. THE UNIT WAS REMOVED FROM SVC. FOUR OTHER UNITS IN THE BUILDING HAVE HAD SIMILAR PROBLEMS WITH THE EXAM LIGHTS' INTENDED STOP MECHANISM NOT FUNCTIONING PROPERLY. THIS ALLOWS THE POWER CORD TO WRAP ITSELF AROUND THE BASE OF THE LIGHT, EVENTUALLY PULLING THE WIRES APART. ALL LIGHTS OF THIS MFR HAVE BEEN TAGGED AND SCHEDULED FOR REMOVAL AND REPLACEMENT. THE MFR SAID THEY HAVE MADE THIS SYSTEM ABOUT 17 YEARS AGO. THE COMPLAINANTS' LIGHT IS ABOUT 6 YEARS OLD. MFR REPORTED THAT THEY HAVE NO SIMILAR COMPLAINTS BUT ARE INVESTIGATING.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 *