BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXSTAR DC1690 DENTAL CHAIR

    MDR report key: 2054075 · Received March 3, 2011

    Report

    Report Number
    3004517290-2011-00001
    Event Type
    Malfunction
    Date Received
    March 3, 2011
    Date of Event
    January 1, 2011
    Report Date
    January 6, 2011
    Manufacturer
    DENTAL EQUIPMENT, LLC (DBA NEWBERG MANUFACTURING)
    Product Code
    KLC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NEWBERG MANUFACTURING 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. THIS COMPLAINT WAS REPORTED TO NEWBERG MANUFACTURING ON (B)(6) 2011. THIS EVENT HAPPENED DURING INSTALLATION AND BASED ON INFORMATION PROVIDED AT THE TIME, WE DETERMINED THAT IT WAS A SINGLE INCIDENT THAT WAS DUE TO AN INSTALLATION ERROR. DURING OUR RECALL INVESTIGATION, WE REVISITED THIS CASE AND DETERMINED THAT THE BOLT ON THIS UNIT HAD THE SAME MALFUNCTION AS THE COMPLAINTS THAT LED TO THE RECALL INVESTIGATION.

    Description of Event or Problem · 1

    A DISTRIBUTOR WAS INSTALLING A DENTAL CHAIR WHEN THE LINK ARM ASSEMBLY THAT HOLDS THE REAR MOUNTED CUSPIDOR BROKE CAUSING THE CUSPIDOR ASSEMBLY TO FALL TO THE FLOOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAXSTAR DC1690 DENTAL CHAIR DENTAL CHAIR KLC DENTAL EQUIPMENT, LLC (DBA NEWBERG MANUFACTURING) DC1690

    Patients

    Seq Age Sex Outcome Treatment
    1