BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC

    MDR report key: 21750833 · Received April 2, 2025

    Report

    Report Number
    3009498591-2025-00008
    Event Type
    Malfunction
    Date Received
    April 2, 2025
    Date of Event
    September 26, 2023
    Report Date
    March 31, 2025
    Manufacturer
    SIEMENS MEDICAL SOLUTIONS USA, INC.
    Product Code
    IYN
    UDI-DI
    04056869173566
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DREW RUS ATTENTION TO SKB0105207, KNOWN ISSUE: PATIENT'S NAME CHANGED TO UNKNOWN UPON REGISTRATION FROM WORKLIST. AND EXPLAINED THIS FURTHERMORE POSSIBLE WORKAROUNDS: HAVE CUSTOMER TO BE AWARE TO CHECK IF STARTED STUDY STILL HAS A PROPER PATIENT NAME ETC. IN IT'S DATA FIELD AND TO EVENTUALLY START AGAIN WITH A NEW QUERY, IF NOT. - DISABLE AUTOQUERY CHECK PATIENT BROWSER WITH CUSTOMER SEARCHING FOR PATIENT ID STARTING WITH "23" OR PATIENT NAME "UNBEKANNT" TO SHOW, THAT NO EXAM DATA HAS GONE LOST. STUDIES SHOULD BE ON THE PACS AS WELL, AS SYSTEM IS SET TO STORE ONSTUDYCLOSE.

    Description of Event or Problem · 0

    COPIED FROM (B)(4). NO IMAGES FOUND IN STUDY AFTER CLOSING IT LOCALLY. SYSTEM WOULD HAVE STORED A STUDY QUERIED FROM MWL SERVER AS "UNBEKANNT" (UNKNOWN).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1264021 SYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC IYN SIEMENS MEDICAL SOLUTIONS USA, INC. 04056869173566

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown