BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HELIOS 3000 WALL MOUNTED LIGHT

    MDR report key: 4307650 · Received November 25, 2014

    Report

    Report Number
    1017522-2014-00015
    Event Type
    Malfunction
    Date Received
    November 25, 2014
    Date of Event
    October 30, 2014
    Report Date
    October 30, 2014
    Manufacturer
    PELTON & CRANE
    Product Code
    EAZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON EVALUATION OF THE LIGHT ARM REAR KNUCKLE ASSEMBLY, IT WAS OBSERVED THAT A PORTION OF THE KNUCKLE HAD BROKEN OFF THE MAIN KNUCKLE ASSEMBLY. THE FRACTURE OF THE KNUCKLE STARTED WHERE THE ROTATIONAL STOP PIN IS LOCATED. THE ROTATIONAL STOP PIN IS DESIGNED TO PREVENT THE OPERATOR FROM ROTATING THE LIGHT MORE THAN 360 DEGREES DURING USE. IT WAS ALSO OBSERVED THAT THE ROTATIONAL STOP PIN WAS MISSING. THE ROUND COUNTER BORE HOLE WHERE THE STOP PIN IS LOCATED WAS DEFORMED IN AN OBLONG SHAPE. THIS IS INDICATIVE OF FORCE BEING APPLIED TO THE ROTATIONAL STOP PIN AS THE DIRECTION OF THE DEFORMATION WAS TOWARDS THE SECTION OF THE KNUCKLE CASTING THAT HAD BROKEN OFF. AS A RESULT, THE ROTATIONAL STOP PIN WAS EXPOSED TO AN EXCESSIVE FORCE DURING USE CAUSING THE FAILURE OF THE KNUCKLE ASSEMBLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A DENTAL PROFESSIONAL WAS MOVING A PELTON AND CRANE HELIOS 3000 DENTAL LIGHT AWAY AFTER USE WHEN THE ARM ASSEMBLY BROKE CAUSING THE LIGHT TO FALL DOWN TOWARDS THE GROUND. THE LIGHT GRAZED THE PATIENT ON THE SIDE OF THEIR HEAD; HOWEVER, THE PATIENT WAS NOT INJURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    766860 HELIOS 3000 WALL MOUNTED LIGHT DENTAL OPERATING LIGHT EAZ PELTON & CRANE HL3WL

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR