BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC

    MDR report key: 21225598 · Received January 23, 2025

    Report

    Report Number
    3009498591-2025-00001
    Event Type
    Malfunction
    Date Received
    January 23, 2025
    Date of Event
    November 14, 2024
    Report Date
    January 24, 2025
    Manufacturer
    SIEMENS MEDICAL SOLUTIONS USA, INC.
    Product Code
    IYN
    UDI-DI
    04056869996295
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    WHAT HAS BEEN DONE SO FAR AND ADDITIONAL INFORMATION: CREATED MINILOGS, FULL LOGS, AND UPLOADED TO KINECTUS CLOUD. ESCALATED TO RSC AND RAISED A PSI. CUSTOMER HAD TO GET ANOTHER SEQUOIA TO COMPLETE THE PATIENT SCAN. SYSTEM ALSO HAD ERROR EARLIER IN THE DAY WHEN BOOTING UP, MESSAGE COUNTRY FILED PSI ---(B)(4). FILING PSI SINCE THE COUNTRY COMPLAINT DOES NOT HAVE COUNTRY RFA NUMBER.

    Description of Event or Problem · 0

    THIS IS A DUPLICATE MDR SUBMISSION TO MFR# 3023245-2024-00064. THE REPORT IS BEING RESUBMITTED DUE TO AN ISSUE WITH OUR INTERNAL COMPLAINT HANDLING TOOL, WHICH PREVENTED THE ORIGINAL REPORT FROM BEING PROPERLY PROCESSED. WE ARE SUBMITTING THIS TO ENSURE THE COMPLAINT IS APPROPRIATELY CLOSED AND ALL NECESSARY DOCUMENTATION IS ACCURATELY REFLECTED IN OUR SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    630274 SYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC IYN SIEMENS MEDICAL SOLUTIONS USA, INC. 04056869996295

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown