BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRIS LIGHT

    MDR report key: 1652590 · Received April 1, 2010

    Report

    Report Number
    1836145-2010-00003
    Event Type
    Malfunction
    Date Received
    April 1, 2010
    Date of Event
    March 3, 2010
    Report Date
    March 3, 2010
    Manufacturer
    HILL-ROM CO. INC, HILL-ROM ARCHITECTURAL PRODUCTS
    Product Code
    KZF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    TECHNICIAN INVESTIGATED AND FOUND THAT THE UPPER LIGHT LENS WAS MELTED BECAUSE AFTER APPROXIMATELY 15 YRS OF HEAT RISING INTO THE UPPER LENS, THE LENS DRY-ROTTED, CRACKED, TOUCHED THE BULB AND MELTED. NO PATIENTS INJURED.

    Description of Event or Problem · 1

    ACCOUNT STATED THAT THE LENS ON THE INDIRECT LIGHT OF P696 LIGHT HAS COME INTO CONTACT WITH THE FLUORESCENT BULB AND HAS MELTED HOLE THE SIZE OF A QUARTER IN THE LENS. LENS HAS ALREADY BEEN REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTEGRIS LIGHT AC POWERED MEDICAL EXAM LIGHT KZF HILL-ROM CO. INC, HILL-ROM ARCHITECTURAL PRODUCTS P696-IL

    Patients

    Seq Age Sex Outcome Treatment
    1