BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KNIGHT

    MDR report key: 1960143 · Received December 21, 2010

    Report

    Report Number
    1523530-2010-00017
    Event Type
    Malfunction
    Date Received
    December 21, 2010
    Date of Event
    December 6, 2010
    Report Date
    December 16, 2010
    Manufacturer
    MIDMARK CORP.
    Product Code
    KLC
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PHOTOGRAPHS OF THE CHAIR FRAME INDICATE THAT THE WELDS HOLDING THE CHAIR TOP TO THE BASE WERE BROKEN. WHEN THE WELDS BROKE, THE CHAIR TOP PIVOTED ALLOWING THE PATIENT TO FALL OUT OF THE CHAIR.

    Description of Event or Problem · 1

    THE UPPER PORTION OF CHAIR CAME APART WITH PATIENT IN CHAIR. THE CHAIR TOP TIPPED ALLOWING THE PATIENT TO FALL TO THE FLOOR. THE PATIENT HIT THEIR HEAD BUT NO INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KNIGHT CHAIR, DENTAL, WITHOUT OPERATIVE UNIT KLC MIDMARK CORP. 152723

    Patients

    Seq Age Sex Outcome Treatment
    1