BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MERGE EYE STATION

    MDR report key: 5435988 · Received February 14, 2016

    Report

    Report Number
    2183926-2016-00447
    Event Type
    Malfunction
    Date Received
    February 14, 2016
    Date of Event
    January 14, 2016
    Report Date
    February 13, 2016
    Manufacturer
    MERGE HEALTHCARE INCORPORATED
    Product Code
    NFJ
    PMA / PMN Number
    K913929
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    MERGE EYESTATION IS INTENDED TO BE USED IN CONJUNCTION WITH EXISTING OPHTHALMIC FUNDUS CAMERAS TO TAKE IMAGES OF THE EYE, PERFORM FLUORESCEIN ANGIOGRAPHY, RED FREE, COLOR AND ICG STILL-IMAGE PHOTOGRAPHY AS WELL AS VIDEO IMAGING. ON (B)(6) 2016 A CUSTOMER CONTACTED MERGE HEALTHCARE AND ALLEGED THAT WHEN THEY EDITED A DICOM SERVICE CLASS PROVIDER (SCP) RECORD IN MERGE EYE STATION, THE IMAGES ARE NO LONGER VIEWABLE IN EYECARE PACS. MERGE SUPPORT WAS ABLE TO CONFIRM THE ALLEGATION THAT IMAGES THAT WERE MODIFIED BY THE CUSTOMER IN EYESTATION, WERE NOT ABLE TO BE VIEWED AS EXPECTED IN EYECARE PACS. THIS MALFUNCTION CAN RESULT IN A DELAY IN DIAGNOSIS OR TREATMENT FOR A PATIENT. (B)(4)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    93038 MERGE EYE STATION OPHTHALMOLOGIC IMAGE PROCESSING SYSTEM NFJ MERGE HEALTHCARE INCORPORATED MERGE EYE STATION 4.3

    Patients

    Seq Age Sex Outcome Treatment
    1 Other