BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HELIOS

    MDR report key: 8054586 · Received November 9, 2018

    Report

    Report Number
    1017522-2018-00028
    Event Type
    Malfunction
    Date Received
    November 9, 2018
    Date of Event
    October 15, 2018
    Report Date
    November 9, 2018
    Manufacturer
    KAVO DENTAL TECHNOLOGIES, LLC
    Product Code
    EAZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    UPON EVALUATION BY THE PELTON & CRANE AUTHORIZED DISTRIBUTOR IT WAS DETERMINED THE LIGHT ARM SET SCREW WAS NOT PROPERLY INSTALLED BY THE DISTRIBUTOR DURING INSTALLATION. THE SET SCREWS WILL PREVENT THE LIGHT FROM UNSCREWING FROM THE LIGHT ARM AFTER INSTALLATION. THE PELTON & CRANE INSTALLATION INSTRUCTIONS CLEARLY STATES TO PROPERLY INSTALL AND SECURE THE SET SCREWS DURING INSTALLATION OF THE DENTAL LIGHT. THE INSTALLATION INSTRUCTIONS ALSO LISTS WARNINGS TO ENSURE THE SET SCREWS ARE INSTALLED AND PROPERLY SECURED. PELTON & CRANCE SHIPPED SET SCREWS TO THE AUTHORIZED PELTON & CRANE DEALER FOR INSTALLATION ON THE DENTAL LIGHT.

    Description of Event or Problem · 1

    A DENTAL ASSISTANT WAS CLEANING A PELTON & CRANE HELIOS DENTAL LIGHT WHEN THE LIGHT CAME APART AND FELL DOWN TOWARDS THE FLOOR HITTING THE DENTAL ASSISTANT ON THE SIDE OF THE HEAD CAUSING A BUMP. THERE WERE NO SERIOUS INJURIES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    895410 HELIOS DENTAL LIGHT EAZ KAVO DENTAL TECHNOLOGIES, LLC HL3C

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR