BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUXSTAR STANDARD UNIT MOUNT LIGHT

    MDR report key: 1315557 · Received February 13, 2009

    Report

    Report Number
    3004517290-2009-00002
    Event Type
    Malfunction
    Date Received
    February 13, 2009
    Date of Event
    January 16, 2009
    Report Date
    January 16, 2009
    Manufacturer
    DENTAL EQUIPMENT, LLC (DBA NEWBERG MANUFACTURING)
    Product Code
    EAZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE PLASTIC LENS HOLDER WAS RETURNED FOR EVALUATION ON 02/03/2009, HOWEVER, THE HEAT SHIELD WAS DISPOSED OF BY THE DOCTOR. THE LENS HOLDER WAS CRACKED, BUT IT APPEARS THIS WAS CAUSED WHEN THE ASSEMBLY STRIKING THE GROUND. THE PLASTIC LENS HOLDER IS 10 YEARS OLD AND HAS SIGNS OF BEING SERVICED MANY TIMES OVER ITS LIFE. THE LENS HEAT SHIELD/HOLDER HAS TO BE REMOVED WHEN REPLACING THE HALOGEN LIGHT BULB OR WHEN CLEANING THE LENS COVERS. THE LENS HEAT SHIELD/HOLDER SNAPS OFF, THEN SNAPS BACK ON WHEN SERVICING IS COMPLETE. THE INSTALLATION INSTRUCTIONS, USE AND CARE INSTRUCTIONS, AND LABELING CLEARLY STATE TO ENSURE THE LENS HEAT SHIELD/HOLDER IS PROPERLY SECURE BY SNAPPING THE PART BACK INTO PLACE.

    Description of Event or Problem · 1

    A DOCTOR WAS POSITIONING THE DENTAL LIGHT FOR USE WHEN THE LENS HEAT SHIELD/HOLDER FELL OFF THE LIGHT AND HIT THE PATIENT. THE LENS HEAT SHIELD/HOLDER WEIGHS LESS THAN ONE POUND, HOWEVER, IT CAN GET HOT DUE TO BEING CLOSE TO THE HALOGEN LIGHT BULB ASSEMBLY. THERE WERE NO INJURIES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LUXSTAR STANDARD UNIT MOUNT LIGHT DENTAL OPERATING LIGHT EAZ DENTAL EQUIPMENT, LLC (DBA NEWBERG MANUFACTURING) UL-1000

    Patients

    Seq Age Sex Outcome Treatment
    1