BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MERGE EYE STATION

    MDR report key: 7156196 · Received December 29, 2017

    Report

    Report Number
    2183926-2017-00215
    Event Type
    Malfunction
    Date Received
    December 29, 2017
    Date of Event
    December 4, 2017
    Report Date
    December 4, 2017
    Manufacturer
    MERGE HEALTHCARE
    Product Code
    HKI
    PMA / PMN Number
    K913929
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FOLLOWING INFORMATION WAS SUBMITTED AS A SUPPLEMENTAL REPORT ON 04/13/2018. THIS SUPPLEMENTAL REPORT IS SUBMITTED TO THE FDA IN ACCORDANCE WITH THE APPLICABLE REGULATIONS AND AS INDICATED BY MERGE HEALTHCARE IN THE INITIAL REPORT SUBMITTED 12/29/2017. DURING TROUBLESHOOTING EFFORTS BETWEEN THE CUSTOMER AND MERGE TECHNICAL SUPPORT, IT WAS FOUND THE ISSUE WAS POSSIBLY RELATED TO THE SYNC BOX, CAMERA, AND/OR TRIGGER CABLE. REPLACEMENT PARTS WERE SENT. ON 04/10/2018, SUPPORT FOLLOWED UP WITH THE ACCOUNT AND THE ISSUE HAD NOT OCCURRED SINCE THE REPLACEMENT PARTS WERE USED.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER'S REPORTED ISSUE(S) ARE STILL UNDER INVESTIGATION. THEREFORE, (B)(4) WAS SELECTED. WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    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) 2017, MERGE HEALTHCARE WAS NOTIFIED THAT AN ACCOUNT WAS UNABLE TO TAKE ICG (INDOCYANINE GREEN CHORIOANGIOGRAPHY) PHOTOGRAPHS. SUPPORT ADJUSTED THE CUSTOMER'S COMMUNICATION DRIVER AND THE ISSUE WAS RESOLVED. ON (B)(6) 2017, MERGE HEALTHCARE WAS CONTACTED AGAIN AND NOTIFIED THAT THE ICG CAMERA WAS NO LONGER WORKING. SUPPORT WORKED WITH THE CUSTOMER AND WAS UNABLE TO GET THE CAMERA TO WORK. IT WAS DETERMINED THE ISSUE WAS POSSIBLY RELATED TO THE SYNC BOX, CAMERA, AND/OR TRIGGER CABLE. REPLACEMENT PARTS WERE SENT. ON (B)(6) 2017, THE CUSTOMER REPORTED THE ISSUE WAS IMPACTING PATIENT CARE AS PATIENTS THAT WERE ALREADY INJECTED WITH DYE COULD NOT COMPLETE TESTING AND HAD TO BE RESCHEDULED. 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 FOR PROCEDURES. NO PATIENT HARM HAS BEEN REPORTED AS A RESULT OF THIS ISSUE. REFERENCE COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    935035 MERGE EYE STATION CAMERA, OPHTHALMIC, AC-POWERED HKI MERGE HEALTHCARE MERGE EYE STATION V11.6

    Patients

    Seq Age Sex Outcome Treatment
    1