BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MERGE EYE STATION

    MDR report key: 5437592 · Received February 15, 2016

    Report

    Report Number
    2183926-2015-00149
    Event Type
    Malfunction
    Date Received
    February 15, 2016
    Date of Event
    October 8, 2015
    Report Date
    February 15, 2016
    Manufacturer
    MERGE HEALTHCARE
    Product Code
    NFJ
    PMA / PMN Number
    K913929
    Removal / Correction Number
    2183926-02/15/2016-044-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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. A PATIENT WAS PREPPED FOR A PROCEDURE WITH DILATED EYES AND THE CUSTOMER WAS UNABLE TO OBTAIN A CAPTURE, WHERE THE SYSTEM STOPPED ALLOWING THE DOWNLOADING OR ACQUISITION OF IMAGES. THIS OCCURRED AFTER ENTERING PATIENT INFORMATION INTO THE EYESTATION APPLICATION, WHEN IT FROZE WHEN TRYING TO START A CAPTURE SESSION. THERE WERE NO ERRORS IN APPLICATION LOG. THE MANUFACTURER COULD NOT SEE ANY ERRORS IN THE SYSTEM EVENT VIEWER. THE DIGITAL CAMERA WAS BEING SEEN BY THE OS PROPERLY. THE CAPTURE STATION WAS REBOOTED. IT WAS DETERMINED TO BE AN SQL DATABASE RELATED ISSUE. IT APPEARS THAT SQL THREADS ARE BEING DEADLOCKED/BLOCKED FOR EXTENDED PERIODS OF TIME, CAUSING ALL CAPTURING TO BE BLOCKED. IT WAS DETERMINED THAT USING THE OLDEST EYESTATION VERSION WITH THE NEWEST EYE CARE PACS WAS CAUSING THE ISSUE. THE SITE WAS ADVISED TO USE THE SAME VERSION RELEASE LEVEL, FOR EXAMPLE (ECP-5.1 AND EYESTATION 11.5.1) OR (ECP-5.0 AND EYESTATION 11.5.0) AS TEMPORARY SOLUTION. THE MANUFACTURER HAS ALSO PROPOSED TO SPLIT DRS AND NON-DRS DATABASES. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    94279 MERGE EYE STATION SYSTEM, IMAGE MANAGEMENT, OPHTHALMIC NFJ MERGE HEALTHCARE MERGE EYESTATION (VERSION 5.0)

    Patients

    Seq Age Sex Outcome Treatment
    1