BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MERGE EYE STATION

    MDR report key: 8114117 · Received November 29, 2018

    Report

    Report Number
    2183926-2018-00091
    Event Type
    Malfunction
    Date Received
    November 29, 2018
    Date of Event
    October 31, 2018
    Report Date
    October 31, 2018
    Manufacturer
    MERGE HEALTHCARE
    Product Code
    HKI
    PMA / PMN Number
    K913929
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MERGE IS CONTINUING TO INVESTIGATE THE ISSUE AND WILL SUBMIT A FOLLOW-UP REPORT.

    Description of Event or Problem · 1

    MERGE EYE STATION 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) 2018, A CUSTOMER REPORTED THAT THE DIGITAL PORTION OF THE CAMERA WAS UPGRADED AND FOLLOWING THE UPGRADE, THE IMAGE QUALITY DETERIORATED. MERGE HEALTHCARE SUPPORT MADE CONFIGURATION CHANGES TO IMPROVE THE IMAGE QUALITY ON THE DEVICE AND THOSE CHANGES WERE REVERTED EACH TIME THE CAMERA WAS POWERED OFF. THE CHANGES MADE BY SUPPORT IMPROVED THE QUALITY OF RED FREE PHOTOS, HOWEVER, THE FUNDUS IMAGES APPEARED ORANGE AND THE FLUORESCEIN ANGIOGRAM (FA) IMAGES APPEARED GRAINY. THIS ISSUE IS BEING REPORTED DUE TO THE POTENTIAL FOR HARM RELATED TO THE INABILITY OF THE EYE CARE PROFESSIONAL TO OBTAIN THE NECESSARY INFORMATION TO INCLUDE NEW PATIENTS WITHIN A CLINICAL TRIAL. FURTHERMORE, THIS IS THE ONLY SYSTEM CERTIFIED FOR CLINICAL STUDIES AND NEW PATIENTS CURRENTLY CANNOT BE ACCEPTED INTO STUDIES. NO PATIENT HARM OCCURRED AS A RESULT OF THIS ISSUE. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    957612 MERGE EYE STATION CAMERA, OPHTHALMIC, AC-POWERED HKI MERGE HEALTHCARE MERGE EYE STATION V11.5.1

    Patients

    Seq Age Sex Outcome Treatment
    1