BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QLAB (PACS) QUANTIFICATION SOFTWARE

    MDR report key: 3886587 · Received April 15, 2014

    Report

    Report Number
    3019216-2014-00006
    Event Type
    Malfunction
    Date Received
    April 15, 2014
    Report Date
    March 18, 2014
    Manufacturer
    PHILIPS ULTRASOUND, INC.
    Product Code
    LLZ
    PMA / PMN Number
    K021966
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL MODEL AND CATALOG #: API 10 CORE MODULE; 989605425222, API 10.1 CORE MODULE. THIS ISSUE IS STILL UNDER INVESTIGATION; THE EFFECT OF THIS ANOMALY IN DISTRIBUTED PRODUCT IS STILL BEING EVALUATED. THERE HAVE BEEN NO REPORTS OF ADVERSE EVENTS FROM THIS ISSUE.

    Description of Event or Problem · 1

    WHEN USING QLAB VERSION 10.0 AND 10.1 FOR THIRD PARTY PACS INTEGRATION, IT IS POSSIBLE TO HAVE ERRONEOUS EJECTION FRACTION (EF) MEASUREMENTS APPEAR IN THE ANALYSIS REPORT PAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    230499 QLAB (PACS) QUANTIFICATION SOFTWARE LLZ PHILIPS ULTRASOUND, INC. 989605425221 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1