BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DCI EQUIPMENT TRACK MOUNT LIGHT ASSEMBLY

    MDR report key: 857384 · Received May 30, 2007

    Report

    Report Number
    3004517290-2007-00001
    Event Type
    Malfunction
    Date Received
    May 30, 2007
    Date of Event
    May 1, 2007
    Report Date
    May 1, 2007
    Manufacturer
    DENTAL EQUIPMENT LLC (DBA NEWBERG MANUFACTURING)
    Product Code
    EAZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AFTER THE MFR, DENTAL EQUIPMENT LLC, REC'D THE CUSTOMER COMPLAINT, AN INTERNAL INVESTIGATION REVEALED THAT THE DENTIST REC'D FOUR DUAL TRACK LIGHTS CONSISTING OF FOUR TRACK ASSEMBLIES FROM PELTON & CRANE (P&C) AND EIGHT LIGHT ASSEMBLIES FROM DENTAL EQUIPMENT LLC. AFTER EVALUATING THE ELECTRICAL SPECS FROM THE P&C TRANSFORMER, IT WAS DISCOVERED THAT DENTAL EQUIPMENT LLC'S LIGHT ASSEMBLIES WERE NOT PROPERLY RATED TO HANDLE THE 2 .9 VAC SUPPLIED FROM THE P&C TRANSFORMER. THE MFR'S LIGHT ASSEMBLY WAS EXCEEDED BY 7 VAC. AS A RESULT OF THE HIGHER VOLTAGE, THE LIGHT BULB OPERATED AT A HIGHER TEMPERATURE CAUSING THE LIGHT SHIELD TO MELT THROUGH THE PLASTIC LIGHT COVER. ALL EIGHT DENTAL EQUIPMENT LLC LIGHT ASSEMBLIES WERE REPLACED WITH EIGHT P&C LIGHT ASSEMBLIES PER P&C FACTORY SPEC.

    Description of Event or Problem · 1

    WHILE THE DENTIST WAS USING THE DENTAL LIGHT DURING PT TREATMENT, THE DENTIST NOTICED THAT THE LIGHT SHIELD WAS MELTING. AS THE DENTIST MOVED THE LIGHT BULB SHIELD ASSEMBLY AWAY FROM THE TREATMENT AREA, IT DROPPED ON HIS GLOVED HAND AND CAME IN CONTACT WITH A TOWEL LOCATED AROUND THE PT'S CHIN AREA. THERE WERE NO INJURES REPORTED. THE BULB SHIELD WEIGHS 12 OUNCES AND WAS APPROX 27 INCHES AWAY DURING USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DCI EQUIPMENT TRACK MOUNT LIGHT ASSEMBLY DENTAL OPERATING LIGHT EAZ DENTAL EQUIPMENT LLC (DBA NEWBERG MANUFACTURING) 1232-110 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention