BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HELIOS 1800 TRACK MOUNTED LIGHT

    MDR report key: 12168609 · Received July 14, 2021

    Report

    Report Number
    1017522-2021-00003
    Event Type
    Malfunction
    Date Received
    July 14, 2021
    Date of Event
    June 24, 2021
    Report Date
    July 14, 2021
    Manufacturer
    KAVO DENTAL TECHNOLOGIES, LLC
    Product Code
    EAZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    UPON EVALUATION BY THE DISTRIBUTOR IT WAS DETERMINED THE ROLL PINS WERE NOT INSTALLED BY THE DISTRIBUTOR DURING INSTALLATION. THE ROLL PINS WILL PREVENT THE LIGHT FROM UNSCREWING FROM THE TROLLEY AFTER INSTALLATION. THE PELTON & CRANE INSTALLATION INSTRUCTIONS CLEARLY STATES TO PROPERLY INSTALL THE ROLL PINS DURING INSTALLATION OF THE TRACK LIGHT. THE INSTALLATION INSTRUCTIONS ALSO LIST WARNINGS TO ENSURE THE ROLL PINS ARE INSTALLED. PELTON & CRANE SHIPPED THE ROLL PINS TO THE AUTHORIZED PELTON & CRANE DEALER TO PROPERLY INSTALL THE DENTAL LIGHT PER THE INSTALLATION INSTRUCTIONS. THIS CONCLUDES THE INVESTIGATION.

    Description of Event or Problem · 1

    DEALER TECHNICIAN CALLED KAVO DENTAL TECHNOLOGIES, LLC AND STATED THAT A PELTON & CRANE HELIOS TRACK LIGHT FELL DOWN TOWARDS THE FLOOR HITTING THE PATIENT ON THEIR KNEE CAUSING A BRUISE. THERE WERE NO SERIOUS INJURIES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1065800 HELIOS 1800 TRACK MOUNTED LIGHT DENTAL LIGHT EAZ KAVO DENTAL TECHNOLOGIES, LLC HLT

    Patients

    Seq Age Sex Outcome Treatment
    1