BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECIALITE

    MDR report key: 799347 · Received December 19, 2006

    Report

    Report Number
    1836145-2006-00004
    Event Type
    Malfunction
    Date Received
    December 19, 2006
    Date of Event
    November 29, 2006
    Report Date
    November 29, 2006
    Manufacturer
    HILL-ROM ARCHITECTURAL PRODUCTS/HILL-ROM CO. INC.
    Product Code
    KZF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO THE HILL-ROM FIELD INVESTIGATION, THE FIRE APPEARED TO HAVE ORIGINATED NEAR THE LEFT SOCKET WHERE FLOURESCENT TUBE CONNECTS. THE DAMAGE TO THE LAMP HOLDER IS LIKELY DUE TO IMPROPER INSTALLATION OF THE FLUORESCENT BULBS. 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

    THE NURSE MGR ALLEGED THE P645 LIGHT CAUGHT FIRE AND HAD TO BE PUT OUT WITH A FIRE EXTINGUISHER. THIS WAS AN OLDER UNIT AND THE CUSTOMER WAS UNABLE TO DETERMINE THE AGE OF THE DEVICE. NO INJURY REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NA