BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXSTAR UNIT-MOUNT LIGHT

    MDR report key: 2280354 · Received October 5, 2011

    Report

    Report Number
    3004517290-2011-00010
    Event Type
    Malfunction
    Date Received
    October 5, 2011
    Date of Event
    September 16, 2011
    Report Date
    September 16, 2011
    Manufacturer
    DENTAL EQUIPMENT LLC (DBA NEWBERG MANUFACTURING)
    Product Code
    EAZ
    Removal / Correction Number
    Z-2834-2011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE LENS HEAT SHIELD/HOLDER FROM THE DENTAL LIGHT HAS A THREE PRONG LOCKING MECHANISM WHICH LOCKS THE LENS HEAT SHIELD/COVER INTO PLACE. THE LENS HEAT SHIELD/COVER HAS TO BE REMOVED BY THE END USER WHEN CLEANING THE LENS OR REPLACING THE HALOGEN BULB DURING ROUTINE OPERATOR MAINTENANCE. 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. DENTAL EQUIPMENT LLC INITIATED A RECALL ON 06/10/2011 TO ADD A TETHER TO THE LENS HEAT SHIELD/COVER TO KEEP IT FROM FALLING OFF THE DENTAL LIGHT IF IT IS NOT RE-INSTALLED PROPERLY. PLEASE REFERENCE FDA RECALL # Z-2834-2011.

    Description of Event or Problem · 1

    A DOCTOR WAS PERFORMING ROUTINE MEDICAL TREATMENT TO A PT WHEN THE LENS HEAT SHIELD/HOLDER FROM HIS DENTAL LIGHT CAME OFF THE LIGHT AND FELL ONTO THE PT. THE DOCTOR BURNED HIS FINGERS WHEN REMOVING THE LENS HEAT SHIELD/HOLDER FROM THE PT. THERE WERE NO SERIOUS INJURIES REPORTED AS BOTH THE PT AND DOCTOR ARE FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAXSTAR UNIT-MOUNT LIGHT DENTAL OPERATING LIGHT EAZ DENTAL EQUIPMENT LLC (DBA NEWBERG MANUFACTURING) ML1000

    Patients

    Seq Age Sex Outcome Treatment
    1