BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FORUM VIEWER

    MDR report key: 4384252 · Received December 30, 2014

    Report

    Report Number
    9615030-2014-00004
    Event Type
    Malfunction
    Date Received
    December 30, 2014
    Date of Event
    November 24, 2014
    Report Date
    September 16, 2015
    Manufacturer
    CARL ZEISS MEDITEC AG
    Product Code
    NFJ
    PMA / PMN Number
    K122938
    Removal / Correction Number
    Z-1049-2015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CHANGE "INITIAL", "30-DAY" TO "FOLLOW-UP # 1";. THE MANUFACTURER HAS INITIATED AN ACTION THAT WAS REPORTED TO THE FDA UNDER 21 USC 360I(F). THE SOFTWARE WAS CORRECTED AT THE FOREIGN SITE WHERE THE MALFUNCTION OCCURRED.

    Description of Event or Problem · 1

    NA

    Description of Event or Problem · 1

    THE HEALTHCARE PROVIDER REPORTED THAT ALTHOUGH THE HIGHLIGHTED B-SCAN IN THE OPTICAL COHERENCE TOMOGRAPHY 5-HD RASTER SCAN OVERLAY ON THE REFERENCE FUNDUS IMAGE MATCHED THE INTENDED SELECTION, THE RETINAL B-SCAN TOMOGRAM DISPLAYED BY FORUM VIEWER SOFTWARE V.3.2.1 FOR THE PATIENT WAS NOT THE B-SCAN TOMOGRAM SELECTED. FOR EXAMPLE, B-SCAN NUMBER 3 OF 5 WAS HIGHLIGHTED IN THE FUNDUS IMAGE BUT B-SCAN NUMBER 1 OF 5 WAS DISPLAYED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    858582 FORUM VIEWER PICTURE ARCHIVE AND COMMUNICATIONS S NFJ CARL ZEISS MEDITEC AG NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other