BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BURTON MEDICAL PRODUCTION CORP.

    MDR report key: 665960 · Received January 13, 2006

    Report

    Report Number
    MW1037726
    Event Type
    Malfunction
    Date Received
    January 13, 2006
    Date of Event
    October 27, 2005
    Report Date
    January 12, 2006
    Manufacturer
    BURTON MEDICAL PRODUCT CORPORATION
    Product Code
    FSY
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    BURTON EXAMINATION LIGHT (WEIGHT APPROXIMATELY 35#) FELL WHILE BEING USED IN THE EMERGENCY DEPARTMENT. NO PATIENT/STAFF INJURY OCCURRED. INVESTIGATION FOUND DEFECTIVE WELD ON ALL BURTON EXAM LIGHTS IN NETWORK (40 LIGHTS). MFR WAS NOTIFIED AND INSPECTED AND IS IN THE PROCESS OF REPLACING DEFECTIVE LIGHTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BURTON MEDICAL PRODUCTION CORP. KKLT 25 EXAMINATION LIGHTS FSY BURTON MEDICAL PRODUCT CORPORATION 0224100 *

    Patients

    Seq Age Sex Outcome Treatment
    1 NA