BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRASOUND

    MDR report key: 21849848 · Received April 16, 2025

    Report

    Report Number
    3009498591-2025-00028
    Event Type
    Malfunction
    Date Received
    April 16, 2025
    Date of Event
    November 5, 2024
    Report Date
    April 16, 2025
    Manufacturer
    SIEMENS MEDICAL SOLUTIONS USA, INC.
    Product Code
    IYN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    WHEN MEASURING D(E) -- > D (B) -- > THEN THE EI/B DISTANCE RATIO IS CALCULATING CORRECTLY.

    Description of Event or Problem · 0

    STRAIN IMAGING EI/B RATIO IS NOT CALCULATED ACCORDING TO MEASUREMENT LABELS. WORKFLOW FOR REPRODUCE: 18L6 BREAST EXAM, VT STRAINING IMAGING 1. MEASUREMENT MODE, ACTIVATE "EI/B RATIO - D" 2. MEASURE DISTANCE ON B MODE IMAGE -- > D (B) MEASUREMENT VALUE IS DISPLAYED ON IMAGE SCREEN. 3. MEASURE DISTANCE ON ELASTO IMAGE -- > D (E) MEASUREMENT VALUE IS DISPLAYED ON IMAGE SCREEN. 4. THE EI /B DISTANCE RATIO IS CALCULATED, BUT RESULT IS B/EI DISTANCE RATIO, NOT EI/B DISTANCE RATIO! (PLEASE REFER TO ATTACHED IMAGE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    105747 ULTRASOUND IYN SIEMENS MEDICAL SOLUTIONS USA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown