BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HELIOS 3000 CABINET MOUNTED LIGHT

    MDR report key: 4377406 · Received December 23, 2014

    Report

    Report Number
    1017522-2014-00017
    Event Type
    Malfunction
    Date Received
    December 23, 2014
    Date of Event
    December 8, 2014
    Report Date
    December 9, 2014
    Manufacturer
    PELTON AND CRANE
    Product Code
    EAZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    UPON VISUAL INSPECTION BY THE LOCAL PELTON AND CRANE DISTRIBUTOR, IT WAS DETERMINED THAT THE LOCKING KEY AND LOCKING KEY SCREW WERE NOT INSTALLED ON THE HELIOS 3000 DENTAL LIGHT ARM. THE FUNCTION OF THE LOCKING KEY AND LOCKING KEY SCREW IS TO SECURE THE LIGHT ARM ASSEMBLY TOGETHER. THE DEVICE WAS NOT RETURNED TO PELTON AND CRANE BUT RATHER IT WAS SERVICED AND PLACED BACK IN USE AT THE DOCTOR'S OFFICE AND HAS BEEN TESTED AND IS NOW FUNCTIONING TO MANUFACTURER'S SPECIFICATIONS. A REVIEW OF PELTON AND CRANE'S HELIOS 3000 DENTAL LIGHT INSTALLATION MANUAL CLEARLY DOCUMENTS AND ILLUSTRATES HOW TO PROPERLY INSTALL THE LOCKING KEY AND LOCKING KEY SCREW DURING INSTALLATION OF THE DENTAL LIGHT. PELTON AND CRANE REVIEWED THE INSTALLATION ISSUE WITH THE DISTRIBUTOR.

    Description of Event or Problem · 1

    A DENTAL PROFESSIONAL WAS PUSHING A PELTON AND CRANE HELIOS 3000 LIGHT AWAY FROM USE WHEN THE LIGHT ARM ASSEMBLY CAME APART AND FELL DOWN TOWARDS THE GROUND. THE LIGHT HEAD HIT THE PT ON THEIR KNEE. THERE WERE NO INJURIES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    847314 HELIOS 3000 CABINET MOUNTED LIGHT DENTAL LIGHT EAZ PELTON AND CRANE HL3CB

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR