BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC

    MDR report key: 23319667 · Received October 16, 2025

    Report

    Report Number
    3019216-2025-000368
    Event Type
    Injury
    Date Received
    October 16, 2025
    Date of Event
    September 17, 2025
    Report Date
    April 24, 2026
    Manufacturer
    PHILIPS ULTRASOUND, INC
    Product Code
    IYN
    PMA / PMN Number
    K192226
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPON SUBSEQUENT FOLLOW UP COMMUNICATIONS WITH THE PHYSICIAN, THE CUSTOMER REPORTED THE PEDIATRIC PATIENT WAS NOT HARMED AS A RESULT OF A PRODUCT DEFECT. HOWEVER, THE USER REPORTED THEY OVERESTIMATED THE SIZE OF RESIDUAL VSD (VENTRICULAR SEPTAL DEFECT) DUE TO THE REPORTED USE ISSUE WITH THE DEVICE. THE REQUIREMENT TO PERFORM ANOTHER CARDIAC BY-PASS RUN ON THE PATIENT MEETS THE CRITERIA AND DEFINITION FOR MEDICAL / SURGICAL INTERVENTION TO PRECLUDE PERMANENT IMPAIRMENT OF A BODY FUNCTION OR PERMANENT DAMAGE TO A BODY STRUCTURE. THE PRODUCT WAS NOT RETURNED FOR ANALYSIS AND REMAINS IN USE AT THE CUSTOMER SITE. THE DEVICE REMAINS IN SERVICE WITH NO SIMILAR ISSUES REPORTED.

    Additional Manufacturer Narrative · 0

    A TECHNICAL EVALUATION OF THE EVENT CONCLUDED THAT THE MODEL X11-4T TRANSDUCER OPERATED IN ACCORDANCE WITH ITS DESIGN SPECIFICATIONS AND PERFORMED AS INTENDED. THE ISSUE WAS ATTRIBUTED TO USER ERROR, SPECIFICALLY RELATED TO TRANSDUCER SELECTION AND ITS USE IN A PEDIATRIC PATIENT POPULATION. THE PRODUCT WAS NOT MISIDENTIFIED, AND ITS LABELING AND INFORMATION WERE CONFIRMED TO BE ACCURATE, COMPLETE, AND COMPLIANT WITH APPLICABLE REQUIREMENTS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE USER WAS UNABLE TO OBSERVE A TRANS-GASTRIC VIEW DURING A CARDIAC BYPASS PROCEDURE WITH THE X11-4T TRANSDUCER, DUE TO LACK OF TRANSDUCER TIP CONTACT. A SECOND CARDIAC BYPASS RUN WAS REQUIRED AS A RESULT OF THE EVENT. ADDITIONAL INFORMATION IS BEING OBTAINED TO DETERMINE PATIENT OUTCOME DETAILS. PHILIPS HAS STARTED AN INVESTIGATION, AND UPON COMPLETION, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2252464 SYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC IYN PHILIPS ULTRASOUND, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention