BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MERGE EYE STATION

    MDR report key: 5976141 · Received September 25, 2016

    Report

    Report Number
    2183926-2016-00721
    Event Type
    Malfunction
    Date Received
    September 25, 2016
    Date of Event
    August 24, 2016
    Report Date
    August 24, 2016
    Manufacturer
    MERGE HEALTHCARE
    Product Code
    HKI
    PMA / PMN Number
    K913929
    Removal / Correction Number
    Z-1142-2017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN ASSISTANT

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER NARRATIVE: 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 09/26/2016. ADDITIONAL INFORMATION, RECEIVED FROM THE ACCOUNT ON 12/24/2017, INDICATES A NEW CAMERA BACK WAS RECEIVED BY THE ACCOUNT AND THE ISSUE WAS RESOLVED. THE OLD CAMERA BACK WAS RETURNED TO TOPCON, THE MANUFACTURER OF THE CAMERA, AND NO DEFECTS WERE FOUND. TOPCON RETURNED THE CAMERA BACK TO MERGE AND THE CAMERA BACK WAS RETURNED TO SERVICE STOCK. NO DIRECT PATIENT IMPACT OCCURRED AS A RESULT OF THE PATIENT RESCHEDULING. CORRECTED DATA: UPDATED CONTACT OFFICE - NAME/ADDRESS DEVICE NOT MADE BY COMPANY. RESOLUTION CODE 4307.

    Additional Manufacturer Narrative · 1

    MERGE HEALTHCARE IS CONTINUING TO INVESTIGATION THIS ISSUE AND IS WORKING WITH THE CUSTOMER TO ENSURE RESOLUTION.

    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 08/24/2016, MERGE HEALTHCARE WAS NOTIFIED THAT THE CAMERA BACK WAS GOING OUT AND THE CUSTOMER WAS LOOKING TO REPAIR OR REPLACE IT. ON 09/02/1016, ADDITIONAL INFORMATION WAS RECEIVED THAT INDICATED THE CAMERA BACK HAS BEEN "VERY LOUD" AND HAS A HARD TIME CONNECTING TO THE COMPUTER. THE CUSTOMER PERFORMS MULTIPLE RESTARTS AND PLUGS AND UNPLUGS THE CAMERA. THESE ACTIVITIES EVENTUALLY ALLOW THE SYSTEM TO CONNECT. AS A RESULT PATIENT CARE WAS DELAYED DUE TO RESCHEDULING OF THE EXAM. WHILE THE SYSTEM IS OPERATIONAL AT TIMES, THIS ISSUE HAS NOT BEEN RESOLVED AT THIS TIME. WITH MERGE EYE STATION NOT FUNCTIONING AS EXPECTED, THERE IS POTENTIAL FOR A DELAY IN CARE THAT RESULTS IN HARM TO A PATIENT. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    627466 MERGE EYE STATION CAMERA, OPHTHALMIC, AC-POWERED HKI MERGE HEALTHCARE MERGE EYE STATION V11.5

    Patients

    Seq Age Sex Outcome Treatment
    1