BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLEARCHART

    MDR report key: 2841563 · Received October 12, 2012

    Report

    Report Number
    2841563
    Event Type
    Malfunction
    Date Received
    October 12, 2012
    Date of Event
    September 13, 2012
    Report Date
    October 12, 2012
    Manufacturer
    REICHERT, INC
    Product Code
    HOX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    THE SCREEN KEEPS GOING OUT AND OCCASIONALLY HAS BLOTCHES ACROSS IT THAT AFFECTS THE UNIFORMITY OF BACK LIGHTING, WHICH MAY MAKE EYE MEASUREMENT USING THIS POTENTIALLY INACCURATE. THE CABINETS ARE TOO SHALLOW AND THE POWER SUPPLY NEEDS TO BE CHANGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLEARCHART CHART, VISUAL ACUITY HOX REICHERT, INC * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *