BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MERGE EYE STATION

    MDR report key: 5437921 · Received February 16, 2016

    Report

    Report Number
    2183926-2015-00317
    Event Type
    Malfunction
    Date Received
    February 16, 2016
    Date of Event
    August 20, 2015
    Report Date
    February 15, 2016
    Manufacturer
    MERGE HEALTHCARE
    Product Code
    NFJ
    PMA / PMN Number
    K913929
    Removal / Correction Number
    2183926-02/15/2016-039-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RESTROSPECTIVE REVIEW, THIS ISSUE WAS DETERMINED TO BE REPORTABLE AS AN MDR.

    Description of Event or Problem · 1

    MERGE EYE STATION IS AN IMAGE CAPTURE SOFTWARE AND DIGITAL INTERFACE FOR USE IN CONJUNCTION WITH EXISTING OPHTHALMIC FUNDUS CAMERAS TO TAKE IMAGES OF THE EYE. IT PERFORMS FLUORESCEIN ANGIOGRAPHY, RED FREE AND COLOR, ICG STILL-IMAGE PHOTOGRAPHY AND VIDEO IMAGING. CUSTOMER REPORTED THERE WAS AN ISSUE WITH HIS PATIENTS' IMAGES NOT COMING UP PROPERLY WHEN IMPORTED THROUGH THE DICOM. IT WAS DISCOVERED THAT THE CUSTOMER SYSTEM WAS SET UP TO VALIDATE WITH PATIENT MRN ONLY. WHEN IMPORTING THROUGH THE ESIU IT WAS PULLING IN OTHER PATIENT DATA BECAUSE IT WAS VALIDATING AGAINST NAME, MRN, AND BIRTHDATE. IT WAS FOUND THAT MULTIPLE PATIENTS WERE POSSIBLY NOT BEING IMPORTED PROPERLY. IN THIS SPECIFIC CASE, THE MRN DID NOT MATCH AN ALREADY EXISTING PATIENT AND THEREFORE, THE DATA WAS IMPORTED UNDER "UNKNOWN". THIS WAS DETERMINED TO BE A POTENTIAL SAFETY ISSUE SHOULD THE IMAGES NOT BE IMPORTED PROPERLY, CAUSING A MISDIAGNOSIS. ON (B)(6) 2015, THE CUSTOMER EXPLAINED THEY ONLY WANT TO VALIDATE ON MRN BECAUSE THEY HAVE DEVICES WHERE THE TECHS ONLY INPUT THE MRNS. HE WOULD LIKE TO USE ESIU AND TO CONTINUE VALIDATING ON MRN ONLY. REFERENCE: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    94906 MERGE EYE STATION SYSTEM, IMAGE MANAGEMENT, OPHTHALMIC NFJ MERGE HEALTHCARE V. 11.3.2

    Patients

    Seq Age Sex Outcome Treatment
    1