BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECIALITE

    MDR report key: 1791835 · Received August 3, 2010

    Report

    Report Number
    1791835
    Event Type
    Malfunction
    Date Received
    August 3, 2010
    Date of Event
    August 2, 2010
    Report Date
    August 3, 2010
    Manufacturer
    HILL ROM
    Product Code
    KZF
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    LAMP HOLDER ON THE PATIENT LIGHT MELTED CAUSING A BURNING/SMOKING IN THE FIXTURE. THERE WAS NO PT HARM. FACILITIES ESTIMATED FLUORESCENT BULBS REPLACED EVERY YEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPECIALITE PATIENT LIGHT KZF HILL ROM P645 *

    Patients

    Seq Age Sex Outcome Treatment
    1 *