BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIAC FUNCTIONAL ANALYSIS (CFA)

    MDR report key: 3040415 · Received March 12, 2013

    Report

    Report Number
    2134213-2013-00002
    Event Type
    Malfunction
    Date Received
    March 12, 2013
    Manufacturer
    VITAL IMAGES, INC.
    Product Code
    LLZ
    PMA / PMN Number
    K052632
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE RISK ASSOCIATED WITH THIS ISSUE IS THAT PT MONITORING, THERAPIES OR TREATMENT MAY BE PROVIDED ERRONEOUSLY BASED ON INCORRECT DATA REPORTED IN THE VITREA MULTI-CHAMBER CFA APPLICATION. A RARE BUT IRREVERSIBLE SERIOUS INJURY MAY OCCUR UNDER NORMAL USE CONDITIONS. THE PRODUCT HAS BEEN IN COMMERCIAL USE FOR APPROXIMATELY FOUR YEARS, WITH 102 SYSTEMS LICENSED WITHIN THE VITREA USER BASE. NO COMPLAINT OR FIELD REPORT HAS BEEN REPORTED.

    Description of Event or Problem · 1

    THE MULTI-CHAMBER CFA ISSUE WAS REPORTED INTERNALLY. IT RELATES TO OUT OF SYNCHRONIZATION SEGMENTATION MODIFICATIONS THAT DO NOT ALIGN TO OUTPUT NUMERICAL VALUES. IT WAS DISCOVERED AND IN CERTAIN WORKFLOW EDITING THE CHAMBER SEGMENTATION DID NOT RESULT IN CORRESPONDING CHANGES TO DATA SHOWN WITHIN TIME VOLUME GRAPHS, INDEXES, AND RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104342 CARDIAC FUNCTIONAL ANALYSIS (CFA) PICTURE ARCHIVING AND COMMUNICATIONS SYS LLZ VITAL IMAGES, INC. 6.4

    Patients

    Seq Age Sex Outcome Treatment
    1