BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPOT PHOTOTHERAPY FLOOR MOUNT LIGHT

    MDR report key: 5327263 · Received September 1, 2004

    Report

    Report Number
    2018492-2004-00017
    Event Type
    Malfunction
    Date Received
    September 1, 2004
    Date of Event
    August 11, 2004
    Report Date
    August 25, 2004
    Manufacturer
    BURTON MEDICAL PRODUCTS CORP.
    Product Code
    FCQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    END USER STATES POSSIBLE CAUSE OF 360 DEGREE ROTATION AS PIVOT SUPPORT PIN SHEARING.

    Description of Event or Problem · 1

    END USER REPORTED THAT LIGHT ROTATED PAST PIVOT STOP RESULTING IN LIGHT TIPPING OVER. LIGHT REPORTED TO HAVE FALLEN AND HITTING AN INCUBATOR. LIGHTS WERE REPORTED AS BEING ABLE TO ROTATE 360 DEGREES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPOT PHOTOTHERAPY FLOOR MOUNT LIGHT FLOORMOUNT FCQ BURTON MEDICAL PRODUCTS CORP. 6600-0287-901

    Patients

    Seq Age Sex Outcome Treatment
    1 NA