BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DC1235 DENTAL CHAIR

    MDR report key: 2040306 · Received February 15, 2011

    Report

    Report Number
    3004517290-2011-00004
    Event Type
    Malfunction
    Date Received
    February 15, 2011
    Date of Event
    February 24, 2011
    Report Date
    February 24, 2011
    Manufacturer
    DENTAL EQUIPMENT, LLC (DBA NEWBERG MFG)
    Product Code
    KLC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NEWBERG MFG RECENTLY BECAME AWARE OF FAILURES OF THE LINK ARM ASSEMBLY THAT CONNECTS SOME REAR MOUNTED OPTIONS (CUSPIDORS, ASSISTANTS INSTRUMENTATION, AND HYGIENE SYSTEMS) TO THE DENTAL CHAIR WHICH MAY POTENTIALLY BREAK AND FALL OFF THE DENTAL CHAIR. OUTSIDE LAB TESTING DETERMINED THAT THE FAILURE WAS DUE TO HYDROGEN EMBRITTLEMENT OF THE LINK ARM BOLT. THIS FAILURE IS CAUSED BY NOT PROPERLY BAKING THE BOLTS AFTER THEY ARE ZINC PLATED IN A TIMELY MANNER. ALL BOLT FAILURES WERE FROM THE SAME LOT NUMBER. A DECISION WAS MADE BY DENTAL EQUIPMENT LLC TO CONDUCT A VOLUNTARY RECALL OF THE AFFECTED LINK ARM ASSEMBLIES.

    Description of Event or Problem · 1

    THE LINK ARM ASSEMBLY WHICH HOLDS THE CUSPIDOR TO THE DENTAL CHAIR BROKEN ALLOWING THE CUSPIDOR TO FALL TO THE FLOOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DC1235 DENTAL CHAIR DENTAL CHAIR KLC DENTAL EQUIPMENT, LLC (DBA NEWBERG MFG) DC1235

    Patients

    Seq Age Sex Outcome Treatment
    1