BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MERGE EYE STATION

    MDR report key: 5437700 · Received February 16, 2016

    Report

    Report Number
    2183926-2015-00318
    Event Type
    Malfunction
    Date Received
    February 16, 2016
    Date of Event
    September 4, 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 RETROSPECTIVE 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 OPTHALMIC 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 THAT THE IMPORTING IS OVERWRITING THE LAST NAME WITH INCORRECTLY SPELLED LAST NAME WHEN TECHNICIAN ENTERS NAME INCORRECTLY. THIS CHANGES THE CURRENT PATIENT INFORMATION IN THE DATABASE TO THE INCORRECTLY SPELLED PATIENT NAME. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    96759 MERGE EYE STATION SYSTEM, IMAGE MANAGEMENT, OPHTHALMIC NFJ MERGE HEALTHCARE V.11.40

    Patients

    Seq Age Sex Outcome Treatment
    1