BEUDAMED
    FDA Adverse Event Other Summary report: N

    SPECIALITE

    MDR report key: 818405 · Received February 12, 2007

    Report

    Report Number
    1836145-2007-00001
    Event Type
    Other
    Date Received
    February 12, 2007
    Date of Event
    January 16, 2007
    Report Date
    January 16, 2007
    Manufacturer
    HILL-ROM CO. INC, HILL-ROM ARCHITECTURAL PRODUCTS
    Product Code
    KZF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO THE HILL-ROM FIELD INVESTIGATION, THE LAMP HOLDER WAS FOUND BURNT DUE TO THE BULB NOT CONNECTED INTO THE LAMP HOLDERS CORRECTLY. THIS CAUSED ARCING AND BURN MARKS ON THE LAMP HOLDER. THE LIGHT HAS BEEN REPLACED. THE FACILITIES RISK MGR WAS SENT THE "IMPORTANT MEDICAL DEVICE BULLETIN: FLUORESCENT LIGHTING FIXTURES DATED MARCH 22, 2002 (ENCLOSED). BEING THAT THIS WOULD OCCUR ON ALL TYPES (USED IN A MEDICAL ENVIRONMENT OR NON MEDICAL ENVIRONMENTS) OF FLUORESCENT LIGHTING FIXTURES AND NOT ISOLATED TO ONLY ONE TYPE, HILL-ROM HAS INFORMED ITS CUSTOMER BASE TO ENSURE PROPER INSTALLATION OF BULBS INTO FIXTURING. REPORT 1836145-02/27/2002-004 C WAS SENT TO THE DETROIT DISTRICT OFFICE.

    Description of Event or Problem · 1

    A NURSE PULLED THE FIRE ALARM DUE TO A BURNING SMELL COMING FROM THE LIGHT. ALLEGEDLY, THERE WERE 11 EMPLOYEES SENT TO EMPLOYEE HEALTH FOR EXAMINATION DUE TO THROAT AND EYE IRRITATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPECIALITE EXAM LIGHT KZF HILL-ROM CO. INC, HILL-ROM ARCHITECTURAL PRODUCTS P645 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA