BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HELIOS 3000 LIGHT

    MDR report key: 18574350 · Received January 24, 2024

    Report

    Report Number
    1017522-2024-00001
    Event Type
    Malfunction
    Date Received
    January 24, 2024
    Date of Event
    January 8, 2024
    Report Date
    January 24, 2024
    Manufacturer
    KAVO DENTAL TECHNOLOGIES, LLC
    Product Code
    EAZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPON EVALUATION BY THE DISTRIBUTOR IT WAS DETERMINED THAT THE DENTAL LIGHT WAS NOT INSTALLED IN ACCORDANCE TO THE PELTON & CRANE MANUFACTURER'S INSTALL INSTRUCTIONS BECAUSE THE ROLL PIN AND SET SCREWS WERE NOT PROPERLY INSTALLED PER THE INSTALLATION INSTRUCTIONS. THE ROLL PIN AND SET SCREWS WILL PREVENT THE LIGHT FROM UNSCREWING FROM THE COLUMN AFTER INSTALLATION. THE PELTON & CRANE INSTALLATION INSTRUCTIONS CLEARLY STATES TO PROPERLY INSTALL THE ROLL PINS AND SET SCREWS DURING INSTALLATION OF THE TRACK MOUNTED LIGHT. THE INSTALLATION INSTRUCTIONS ALSO LIST WARNINGS TO ENSURE THE ROLL PINS AND SET SCREWS ARE INSTALLED. THE AUTHORIZED PELTON & CRANE DEALER REINSTALLED THE LIGHT CONFIRMING PROPER INSTALLMENT WITH THE ROLL PIN AND SET SCREWS PER THE INSTALLATION INSTRUCTIONS. THIS CONCLUDES THE INVESTIGATION.

    Description of Event or Problem · 0

    DEALER TECHNICIAN CALLED KAVO DENTAL TECHNOLOGIES, LLC AND STATED THAT A PELTON & CRANE HELIOS TRACK LIGHT FELL DOWN TOWARDS THE FLOOR. THE DOCTOR'S OFFICE CONFIRMED THE LIGHT ARM GRAZED THE RIGHT CALF AREA OF THE PATIENT'S LEG WITH NO OBVIOUS SIGNS OF TRAUMA. THERE WERE NO SERIOUS INJURIES OR MEDICAL INTERVENTION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2400740 HELIOS 3000 LIGHT DENTAL LIGHT EAZ KAVO DENTAL TECHNOLOGIES, LLC HL3T

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Female