BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HELIOS 3000 TRACK MOUNT LIGHT

    MDR report key: 3533016 · Received October 24, 2013

    Report

    Report Number
    1017522-2013-00020
    Event Type
    Malfunction
    Date Received
    October 24, 2013
    Date of Event
    September 26, 2013
    Report Date
    September 27, 2013
    Manufacturer
    PELTON & CRANE
    Product Code
    EAZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    UPON EVALUATION BY THE LOCAL PELTON AND CRANE DISTRIBUTOR IT WAS DETERMINED THE SET SCREWS WERE NOT PROPERLY TIGHTENED ON THE HELIOS 3000 DENTAL LIGHT ARM ASSEMBLY. THE FUNCTION OF THE SET SCREW IS TO PREVENT THE LIGHT FROM UNSCREWING FROM THE POLE AFTER INSTALLATION. THE PELTON AND CRANE USE AND CARE AND INSTALLATION INSTRUCTIONS HAS A WARNING THAT CLEARLY STATES TO PROPERLY TIGHTEN THE SET SCREWS DURING THE INSTALLATION PROCESS. THIS IS ALSO LISTED AS A VERIFICATION ON THE INSTALLATION CHECKLIST TO CHECK ALL SET SCREWS.

    Description of Event or Problem · 1

    A DENTIST WAS POSITIONING A PELTON AND CRANE DENTAL LIGHT FOR USE WHEN THE DENTAL LIGHT FELL FROM THE TRACK ASSEMBLY AND ONTO THE PATIENTS STOMACH. THERE WERE NO INJURIES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    547758 HELIOS 3000 TRACK MOUNT LIGHT DENTAL OPERATING LIGHT EAZ PELTON & CRANE HL3T

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR