BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELEVANCE

    MDR report key: 3881252 · Received February 14, 2014

    Report

    Report Number
    1523530-2014-00003
    Event Type
    Malfunction
    Date Received
    February 14, 2014
    Date of Event
    January 17, 2014
    Report Date
    February 14, 2014
    Manufacturer
    MIDMARK CORPORATION
    Product Code
    EIA
    PMA / PMN Number
    K120239
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION DETERMINED THAT THE ROTATION ARM WAS NOT INSTALLED CORRECTLY. THIS CAUSED THE FAILURE TO OCCUR. A SERVICE TECHNICIAN REVIEWED, INSTALLED, AND PERFORMED FUNCTIONAL CHECKS TO COMPLETE REPAIR.

    Description of Event or Problem · 1

    DENTAL UNIT ARM SEPARATED FROM THE ATTACHMENT POINT ON THE DENTAL CHAIR. NO INJURIES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    97285 ELEVANCE DENTAL UNIT EIA MIDMARK CORPORATION 153600-007

    Patients

    Seq Age Sex Outcome Treatment
    1