BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MERGE EYE STATION

    MDR report key: 5437603 · Received February 16, 2016

    Report

    Report Number
    2183926-2015-00169
    Event Type
    Malfunction
    Date Received
    February 16, 2016
    Date of Event
    August 14, 2014
    Report Date
    February 15, 2016
    Manufacturer
    MERGE HEALTHCARE
    Product Code
    NFJ
    PMA / PMN Number
    K913929
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RETROSPECTIVE REVIEW, THIS ISSUE WAS DETERMINED TO BE REPORTABLE AS AN MDR.

    Description of Event or Problem · 1

    MERGE EYE STATION CONVERTS AN EXISTING FUNDUS CAMERA OR SLIT LAMP TO A FULLY-DIGITAL SYSTEM THAT PRODUCES JOURNAL QUALITY IMAGES. WITH SOLUTIONS UP TO 18 MEGAPIXELS THE IMAGE QUALITY QUALITY CAN BE IMPROVED WITHOUT REPLACING YOUR FUNDUS CAMERA, ALLOWING TO MORE EFFICIENTLY DIAGNOSE A PATIENT. THE CUSTOMER FILED AN ISSUE FOR A PATIENT WHERE THE IMAGES ARE LOADING CORRECTLY BUT BECOME VERY DARK. THE POOR QUALITY OF THE IMAGES PREVENTS THE DOCTOR'S ABILLITY TO PERFORM PROGRESSION ANALYSIS PROPERLY AND ULTIMATELY THE PATIENT DIAGNOSIS. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    96611 MERGE EYE STATION OPHTHALMIC NFJ MERGE HEALTHCARE MERGE EYE STATION (VERSION NOT REPORTED)

    Patients

    Seq Age Sex Outcome Treatment
    1