BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LFII CHAIR MOUNTED LIGHT

    MDR report key: 3901969 · Received February 20, 2014

    Report

    Report Number
    1017522-2014-00002
    Event Type
    Malfunction
    Date Received
    February 20, 2014
    Date of Event
    January 24, 2014
    Report Date
    January 24, 2014
    Manufacturer
    PELTON & CRANE
    Product Code
    EAZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON EVALUATION BY THE LOCAL DISTRIBUTION IT WAS DETERMINED THE LIGHT ARM UNTHREADED FROM THE CHAIR POST ASSEMBLY DUE TO THE LIGHT ARM ADAPTER BEING TOO TIGHT ON THE CHAIR POST ASSEMBLY. THE LIGHT ARM IS DESIGNED TO ROTATE FREELY ON THE POST ASSEMBLY AND DUE TO THE TIGHT CONNECTOR THE LIGHT ARM COULD NOT ROTATE PROPERLY RESULTING IN THE LIGHT ARM TO UNTHREADED FROM THE POST ASSEMBLY. THE CHAIR POST ASSEMBLY WAS NOT MANUFACTURING BY PELTON AND CRANE AND IS NOT WITHIN MANUFACTURERS SPECIFICATIONS. ALSO THE PELTON AND CRANE DENTAL LIGHT IS OVER 20 YEARS OLD AND IS PAST THE EXPECTED LIFE OF THE DEVICE.

    Description of Event or Problem · 1

    A DENTIST WAS POSITIONING A PELTON AND CRANE CHAIR MOUNTED DENTAL LIGHT FOR USE WHEN THE DENTAL LIGHT FELL ON THE PATIENT. THERE WAS NO SERIOUS INJURIES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    108430 LFII CHAIR MOUNTED LIGHT DENTAL OPERATING LIGHT EAZ PELTON & CRANE HBU

    Patients

    Seq Age Sex Outcome Treatment
    1