BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INCANDESCENT LAMP

    MDR report key: 38023 · Received September 16, 1996

    Report

    Report Number
    MW4001490
    Event Type
    Malfunction
    Date Received
    September 16, 1996
    Report Date
    May 17, 1996
    Manufacturer
    BULBTRONICS
    Product Code
    EAZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    SUSPECTED MFG DEFECT. THESE LAMPS ARE IDENTIFIED AS REPLACEMENT BULBS FOR A SPECIFIC BRAND DENTAL OPERATING LIGHTS. HOWEVER, THE LAMPS ARE OF INSUFFICIENT LENGTH TO MAKE FIRM CONTACT WITH THE LAMP HOLDER SOCKETS WHICH CREATES AN INTERMITTENT CONTINUITY CONDITION. THIS LEADS TO ELECTRICAL ARCING AND SUBSEQUENT CARBON BUILD UP ON THE SOCKET AND BULB CONTACT SURFACES. THIS CONDITION REQUIRES REPLACEMENT OF BOTH THE SOCKETS AND BULB. ADDING TO THE PROBLEM IS POOR QUALITY FINISH ON THE BULB ENDS WHICH HASTEN THE CARBON BUILD UP. WORK ORDER REVIEW INDICATES 18 SOCKETS WERE REPLACED DUE TO THIS CONDITION, AT $ 27.00 EACH, IN THE LAST SIX MONTHS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INCANDESCENT LAMP INCANDESCENT LAMP EAZ BULBTRONICS * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *