BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MERGE EYESTATION

    MDR report key: 5415351 · Received February 7, 2016

    Report

    Report Number
    2183926-2015-00050
    Event Type
    Malfunction
    Date Received
    February 7, 2016
    Date of Event
    November 19, 2015
    Report Date
    February 7, 2016
    Manufacturer
    MERGE HEALTHCARE
    Product Code
    NFJ
    PMA / PMN Number
    K913929
    Removal / Correction Number
    Z-1828-2017; RES 76844
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    SUBMITTING THIS SUPPLEMENTAL REPORT TO ADD FDA CORRECTION AND REMOVAL REFERENCE NUMBERS.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT IMAGES WERE LOST DUE TO ANTIVIRUS REAL TIME SCAN WHEN CAPTURING WITH EYE STATION. THE IMAGES LOST WERE FUNDUS PHOTOGRAPHY IMAGES FROM OUR MERGE/OIS CAPTURE STATION FROM ONE PATIENT. OF THE THREE IMAGES TWO WERE NOT RECOVERED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    73627 MERGE EYESTATION SYSTEM, IMAGE MANAGEMENT, OPTHALMIC NFJ MERGE HEALTHCARE MERGE EYESTATION 11.1.38

    Patients

    Seq Age Sex Outcome Treatment
    1