BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HELIOS 3000 CEILING MOUNTED DENTAL LIGHT

    MDR report key: 3964321 · Received June 19, 2014

    Report

    Report Number
    1017522-2014-00008
    Event Type
    Malfunction
    Date Received
    June 19, 2014
    Date of Event
    May 23, 2014
    Report Date
    May 27, 2014
    Manufacturer
    PELTON & CRANE
    Product Code
    EAZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    UPON EVALUATION BY THE LOCAL PELTON AND CRANE DISTRIBUTOR IT WAS DETERMINED THE SET SCREWS AND ROLL PIN WERE NOT INSTALLED BY THE DISTRIBUTOR DURING INSTALLATION. THE SET SCREWS AND ROLL PIN WILL PREVENT THE LIGHT FROM UNSCREWING FROM THE POLE AFTER INSTALLATION. PELTON AND CRANE REVIEWED WITH THE DISTRIBUTOR THE PROPER INSTALLATION PROCESS OF THE SET SCREWS AND ROLL PINS.

    Description of Event or Problem · 1

    THE DENTIST WAS POSITIONING A PELTON AND CRANE HELIOS CEILING MOUNTED DENTAL LIGHT FOR USE WHEN THE LIGHT FELL DOWN TOWARDS THE FLOOR HITTING THE DENTIST ON HIS ARM CAUSING A CONTUSION. A SECOND PERSON (PATIENT) WAS INVOLVED IN THE EVENT. PLEASE SEE MFR #1017522-2014-00007.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    359362 HELIOS 3000 CEILING MOUNTED DENTAL LIGHT DENTAL OPERATING LIGHT EAZ PELTON & CRANE HL3C

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR