BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EPIQ CVX DIAGNOSTIC ULTRASOUND SYSTEM

    MDR report key: 23607698 · Received November 20, 2025

    Report

    Report Number
    3019216-2025-000448
    Event Type
    Injury
    Date Received
    November 20, 2025
    Date of Event
    October 24, 2025
    Report Date
    January 28, 2026
    Manufacturer
    PHILIPS ULTRASOUND, INC
    Product Code
    IYN
    UDI-DI
    00884838107526
    PMA / PMN Number
    K132304
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A THOROUGH INVESTIGATION WAS PERFORMED WHICH INCLUDED EDGES AND PROJECTION TESTS ON THE TRANSDUCER TIP AND INSERTION TUBE. THE INVESTIGATION DETERMINED THE TRANSDUCER DID NOT HAVE ANY SHARP EDGES OR DAMAGE TO THE EXTERIOR SHEATH IN SUCH A WAY THAT COULD CAUSE AN ESOPHAGEAL TEAR. THERE WAS NO INDICATION OF EITHER NON-CONFORMING MATERIAL AND NO INDICATION OF DESIGN ANOMALY REQUIRING FURTHER ACTION. THE PHILIPS SERVICE ENGINEER REPLACED THE TRANSDUCER TO ADDRESS THE CUSTOMER¿S IMMEDIATE CONCERN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT EXPERIENCED AN ESOPHAGEAL TEAR DURING AN ECHOCARDIOGRAM WITH THE TRANSESOPHAGEAL X8-2T TRANSDUCER AND EPIQ CVX ULTRASOUND SYSTEM. ADDITIONAL INFORMATION IS BEING OBTAINED REGARDING PATIENT OUTCOME. THE PHILIPS SERVICE ENGINEER REPLACED THE TRANSDUCER TO ADDRESS THE CUSTOMER¿S IMMEDIATE CONCERN. 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
    262171 EPIQ CVX DIAGNOSTIC ULTRASOUND SYSTEM SYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC IYN PHILIPS ULTRASOUND, INC 795231 00884838107526

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention