BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MERGE EYE STATION

    MDR report key: 5912946 · Received August 29, 2016

    Report

    Report Number
    2183926-2016-00702
    Event Type
    Malfunction
    Date Received
    August 29, 2016
    Date of Event
    July 29, 2016
    Report Date
    July 29, 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
    AL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL 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 08/30/2016. TO TROUBLESHOOT THE ISSUE, THE CUSTOMER REPORTED THEY REPLACED THE FIREWIRE CARD AND HANDLED THE REST OF THE ISSUES WITHIN THEIR OWN INTERNAL DEPARTMENT. DUE TO PRICING REASONS, THE ACCOUNT DID NOT WANT TO PURSUE ANY MORE ASSISTANCE WITH THE SUPPORT DEPARTMENT. ON 02/26/2018, THE CUSTOMER REPORTED IMAGES CAME IN UNDER DEVELOPED. THE CUSTOMER REBOOTED THE SYSTEM AND THE SOFTWARE WOULD NO LONGER LOAD. SUPPORT HAD THE CUSTOMER RESET THE STATION BACK TO THE LEGACY DRIVER AND THE ISSUE WAS RESOLVED. TO DATE, THE ISSUE HAS NOT BEEN REPORTED AGAIN. REFERENCE CASE (B)(4). UPDATE TO MFR SITE - REPORT SOURCE CONTACT INFORMATION. - EVALUATION CODES: METHOD: 10: ACTUAL DEVICE EVALUATED. RESULTS: 3213 INTEROPERABILITY PROBLEM. CONCLUSIONS: 4307: COMPONENT FAILURE.

    Additional Manufacturer Narrative · 1

    MERGE HEALTHCARE IS CONTINUING TO INVESTIGATE THE CUSTOMER'S ALLEGATION.

    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 07/29/2016, MERGE HEALTHCARE RECEIVED INFORMATION REGARDING A CAMERA THAT WAS NOT CONNECTING TO THE EYE STATION. ACCORDING TO THE CUSTOMER, THE FIREWIRE CARD HAD ALREADY BEEN REPLACED AND THE SYSTEM WAS STILL NOT FUNCTIONING. ON 08/04/2016, FOLLOW-UP WITH THE CUSTOMER INDICATED THAT MOST PATIENTS WERE ABLE TO HAVE IMAGING PERFORMED BY ANOTHER SYSTEM (HEIDELBERG). THE CUSTOMER REPORTED THAT THREE (3) PATIENTS HAD TO BE RESCHEDULED FOR FUNDUS PHOTOS, AS THE WIDE FIELD IMAGING WAS NOT AVAILABLE, EXCEPT THROUGH THE EYE STATION. WITH MERGE EYE STATION NOT PERFORMING AS EXPECTED, THERE IS A POTENTIAL FOR A DELAY IN DIAGNOSIS OR TREATMENT FOR A PATIENT THAT MAY RESULT IN HARM. HOWEVER, THERE IS NO INDICATION OF ANY DIRECT PATIENT IMPACT THAT HAS BEEN REPORTED AS A RESULT OF THE DELAY. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    561811 MERGE EYE STATION CAMERA, OPHTHALMIC, AC-POWERED HKI MERGE HEALTHCARE MERGE EYE STATION V11.4

    Patients

    Seq Age Sex Outcome Treatment
    1