BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRASOUND

    MDR report key: 21849851 · Received April 16, 2025

    Report

    Report Number
    3009498591-2025-00032
    Event Type
    Malfunction
    Date Received
    April 16, 2025
    Date of Event
    March 11, 2024
    Report Date
    April 16, 2025
    Manufacturer
    SIEMENS MEDICAL SOLUTIONS USA, INC.
    Product Code
    IYN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    * ORDER MADE TO REPLACE THIS PROBE. NO STOCK AT THE MOMENT. REQUEST TO * ACCELERATE THE REPLENISHMENT MADE TO LOGISTICS DUE TO THIS PSI. COUNTRY RFA, PROVIDED VIA PQIF COMPLAINT FORM: FRANCE.

    Description of Event or Problem · 0

    THIS COMPLAINT TICKET IS BEING MIGRATED FROM GSMS (PM00376703 , DATE COMPLAINT CREATED: 03/14/2024) TO SMARTSOLVE AS A PART OF THE GSMS SUNSET PROJECT (GSMS SHUTS DOWN ON 01-OCT-2024). THE INVESTIGATION WILL BE COMPLETED AND DOCUMENTED IN THE SMARTSOLVE COMPLAINT TICKET. * GOOD MORNING, * THE 6C1 PROBE OF THIS ULTRASOUND SYSTEM HAS ELECTRICAL INSULATION * PROBLEMS. IN FACT, PATIENTS FEEL TINGLING COMING FROM THIS PROBE DURING * ULTRASOUNDS. * THE PROBE MEMBRANE APPEARS POROUS. * THE 6C1 PROBE HAS THE REFERENCE: 10135941 AND THE SERIAL NUMBER: (B)(6). * WE HAVE PLACED AN ORDER TO REPLACE THIS ONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    105750 ULTRASOUND IYN SIEMENS MEDICAL SOLUTIONS USA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown