BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MERGE EYE STATION

    MDR report key: 5437932 · Received February 16, 2016

    Report

    Report Number
    2183926-2015-00319
    Event Type
    Malfunction
    Date Received
    February 16, 2016
    Date of Event
    July 20, 2015
    Report Date
    February 15, 2016
    Manufacturer
    MERGE HEALTHCARE
    Product Code
    NFJ
    PMA / PMN Number
    K913929
    Removal / Correction Number
    2183926-02/15/2016-039-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    MERGE EYE STATION IS AN IMAGE CAPTURE SOFTWARE AND DIGITAL INTERFACE FOR USE IN CONJUNCTION WITH EXISTING OPTHALIC FUNDUS CAMERAS TO TAKE IMAGES OF THE EYE. IT PERFORMS FLUORESCEIN ANGIOGRAPHY, REF FREE AND COLOR, ICG STILL-IMAGE PHOTOGRAPHY AND VIDEO IMAGING. ON 7/20/15, MERGE WAS CONTACTED TO REPORT THAT IMAGES WERE IMPORTED UNDER "UNKNOWN". MERGE TOOK OUT L FOR COMPAREPATIENT_DB IN ESIU ON ALL IMPORT STATIONS. THE CUSTOMER WAS SHOWN HOW TO COMPLETE THIS AND THE SYSTEM WAS RESTARTED. THE SYSTEMS ARE DESIGN TO ALLOW SITES TO VALIDATE PATIENT INFORMATION AT THE TIME OF IMPORT ON ONE PATIENT'S DEMOGRAPHICS. ADDITIONALLY, CERTAIN RELEASES WILL OVERWRITE THE PATIENT NAME IF THE MEDICAL RECORD NUMBERS (MRNS) MATCH BUT THE NAMES DO NOT OR WILL IMPORT THE PATIENT DATA AS "UNKNOWN". VALIDATION ON ONE PATIENT'S DEMOGRAPHICS COULD POTENTIALLY INTRODUCE PATIENT DATA MIXUP OR DELAY IN PATIENT CARE. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    96186 MERGE EYE STATION SYSTEM, IMAGE MANAGEMENT, OPHTHALMIC NFJ MERGE HEALTHCARE MERGE EYE STATION

    Patients

    Seq Age Sex Outcome Treatment
    1