BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HELIOS 3000 ELLIPSE SYSTEM LIGHT

    MDR report key: 2802465 · Received October 18, 2012

    Report

    Report Number
    1017522-2012-00024
    Event Type
    Malfunction
    Date Received
    October 18, 2012
    Date of Event
    September 18, 2012
    Report Date
    September 19, 2012
    Manufacturer
    PELTON & CRANE
    Product Code
    EAZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DISTRIBUTOR SERVICE TECHNICIAN INFORMED PELTON AND CRANE THAT THE TWO SET SCREWS THAT SECURES THE LIGHT ARM TO THE POST ASSEMBLY WERE LOOSE. THE TECHNICIAN THEN REASSEMBLED THE LIGHT ARM TO THE LIGHT POST AND PROPERLY TIGHTENED THE SET SCREWS.

    Description of Event or Problem · 1

    A PATIENT WAS EXITING A DENTAL CHAIR WHEN A PELTON AND CRANE CHAIR MOUNTED DENTAL LIGHT ARM ASSEMBLY SEPARATED FROM THE CHAIR POST ASSEMBLY CAUSING THE DENTAL LIGHT AND ARM TO FALL DOWN ONTO THE DENTAL CHAIR. THERE WERE NO INJURIES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HELIOS 3000 ELLIPSE SYSTEM LIGHT DENTAL LIGHT EAZ PELTON & CRANE HL3SE

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR