BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MERGE EYE STATION

    MDR report key: 5437547 · Received February 15, 2016

    Report

    Report Number
    2183926-2015-00117
    Event Type
    Malfunction
    Date Received
    February 15, 2016
    Date of Event
    November 12, 2015
    Report Date
    February 15, 2016
    Manufacturer
    MERGE HEALTHCARE
    Product Code
    NFJ
    PMA / PMN Number
    K913929
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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 IS A SYSTEM DEVELOPED BY MERGE WHICH IN REAL TIME, CONVERTS THE EXISTING FUNDUS CAMERA OR SLIT LAMP TO A FULLY-DIGITAL SYSTEM. THE RESULTS ARE JOURNAL QUALITY IMAGES. WITH SOLUTIONS UP TO 18 MEGAPIXELS, THE IMAGE QUALITY IS IMPROVED WITHOUT REPLACING THE FUNDUS CAMERA, ALLOWING AN EFFICIENT PATIENT DIAGNOSIS. ON (B)(6) 2015, THE CUSTOMER REPORTED THAT NONE OF THEIR FA IMAGES FROM ANY SITE WERE SHOWING UP ON SYMPHONY WEB. SUPPORT WAS ABLE TO REMOTE IN TO THEIR SERVER AND DID NOT SEE ANY OF THE FA SHOWING UP IN SYMPHONY WEB. SUPPORT ALSO LOGGED INTO THE CAPTURE STATION TO CHECK THE WINSTATION CAPTURE AND REVIEW TO SEE IF THE IMAGES WOULD SHOW UP THERE, HOWEVER, THERE WERE GAPS IN THE WINSTATION RECORDS. IT WAS DISCOVERED THAT THIS ISSUE OCCURED BECAUSE A USER DELETED INFORMATION FROM THE DATABASE. THERE IS ALSO THE POTENTIAL THAT THE USER WAS UNDER THE IMPRESSION THAT ONLY ONE PROCEDURE WAS SELECTED WHILE THERE WERE MULTIPLE PROCEDURES SELECTED. THE SYSTEM DOES NOT HAVE ANY RESTRICTIONS ON WHO CAN ACCESS THE DATABASE AND DELETE PROCEDURES/IMAGES. THIS WAS DETERMINED TO BE A POTENTIAL SAFETY ISSUE TO A PATIENT IN THE EVENT IMAGES USED FOR A DIAGNOSIS OF A PATIENT ARE INADVERTENTLY DELETED. MERGE WAS ABLE TO RETRIEVE IMAGES FOR DELETED PROCEDURES AND RE-IMPORT THEM USING IMPORT FROM ANOTHER WINSTATION UTILITY IN THE SOFTWARE. SOME PROCEDURES FOR FA WERE STILL MISSING AND WILL NEED TO BE RETAKEN. THIS ISSUE OCCURRED BECAUSE A USER DELETED INFORMATION FROM THE DATABASE. THERE IS ALSO THE POTENTIAL THAT THE USER WAS UNDER THE IMPRESSION THAT ONLY ONE PROCEDURE WAS SELECTED WHILE THERE WERE MULTIPLE PROCEDURES SELECTED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    93436 MERGE EYE STATION SYSTEM, IMAGE MANAGEMENT, OPHTHALMIC NFJ MERGE HEALTHCARE MERGE EYE STATION V. 10.6.61

    Patients

    Seq Age Sex Outcome Treatment
    1