BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EPIQ DIAGNOSTIC ULTRASOUND SYSTEM

    MDR report key: 24708786 · Received March 30, 2026

    Report

    Report Number
    3019216-2026-100114
    Event Type
    Injury
    Date Received
    March 30, 2026
    Date of Event
    February 25, 2026
    Report Date
    May 19, 2026
    Manufacturer
    PHILIPS ULTRASOUND, INC
    Product Code
    IYN
    UDI-DI
    00884838123960
    PMA / PMN Number
    K132304
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A FIELD SERVICE ENGINEER EVALUATED THE X8-2T TRANSDUCER IN RESPONSE TO THE CUSTOMER'S COMPLAINT. THE ENGINEER TESTED THE ARTICULATION MECHANISM AND STEERING KNOB FUNCTIONALITY, CONFIRMING THAT THE TRANSDUCER WAS FULLY CAPABLE OF ARTICULATING IN ALL DIRECTIONS AND WAS NOT STUCK IN A BENT POSITION. WHEN ARTICULATED THROUGH ITS FULL RANGE OF MOTION, THE TRANSDUCER COULD ALSO BE RETURNED TO THE NEUTRAL POSITION WITHOUT ANY RESISTANCE. NO FAULTS OR OPERATIONAL ISSUES WERE IDENTIFIED WITH THE ARTICULATION MECHANISM, AND ALL FUNCTIONAL ISSUES PASSED. BECAUSE THE CUSTOMER DECLINED TO RETURN THE TRANSDUCER, NO ADDITIONAL INVESTIGATION COULD BE PERFORMED. THE SYSTEM HAS SINCE BEEN RETURNED TO SERVICE, AND NO SIMILAR ISSUES HAVE BEEN REPORTED. NO FURTHER DETAILS ABOUT THE PATIENT'S CLINICAL OUTCOME COULD BE OBTAINED.

    Additional Manufacturer Narrative · 0

    THIS IS SUPPLEMENTAL REPORT ONLY, REF: MEDWATCH MW5185243. THIS EVENT HAS ALREADY BEEN REPORTED TO FDA, REF: MFR REPORT NUMBER 3019216-2026-100114.

    Description of Event or Problem · 0

    A CUSTOMER REPORTED THAT WHEN THE X8-2T TRANSDUCER WAS REMOVED FROM A PATIENT DURING A TRANSESOPHAGEAL EXAM, THE TIP WAS STILL IN THE BENT POSITION AND THE PATIENT WAS POSSIBLY HARMED DURING THIS PROCEDURE. THE TRANSDUCER WAS ASSOCIATED WITH THE EPIQ CVX ULTRASOUND SYSTEM. ADDITIONAL INFORMATION IS BEING OBTAINED TO DETERMINE PATIENT OUTCOME. PHILIPS HAS STARTED AN INVESTIGATION, AND UPON COMPLETION, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    THIS IS SUPPLEMENTAL REPORT ONLY, REF: MEDWATCH MW5185243. THIS EVENT HAS ALREADY BEEN REPORTED TO FDA, REF: MFR REPORT NUMBER 3019216-2026-100114.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    374309 EPIQ DIAGNOSTIC ULTRASOUND SYSTEM SYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC IYN PHILIPS ULTRASOUND, INC 795231 00884838123960

    Patients

    Seq Age Sex Outcome Treatment
    1