BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EPIQ CVX DIAGNOSTIC ULTRASOUND SYSTEM

    MDR report key: 23727913 · Received December 5, 2025

    Report

    Report Number
    3019216-2025-000469
    Event Type
    Malfunction
    Date Received
    December 5, 2025
    Date of Event
    November 12, 2025
    Report Date
    April 24, 2026
    Manufacturer
    PHILIPS ULTRASOUND, INC
    Product Code
    IYN
    UDI-DI
    00884838107526
    PMA / PMN Number
    K132304
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A QUALIFIED FIELD SERVICE ENGINEER REPLACED THE AFFECTED TRANSDUCER TO RESOLVE THE CUSTOMER'S IMMEDIATE CONCERNS. AN INVESTIGATION WAS PERFORMED WHICH CONFIRMED THE TRANSDUCER HAD CORROSION/FLUID INGRESS WITHIN THE RACK ACTUATOR. THE ENGINEERING TEAM OBSERVED THE PRESENCE OF NON-PHILIPS MATERIAL, INDICATING THIRD PARTY REPAIR. AS THE TRANSDUCER WAS REPAIRED BY A THIRD PARTY, NO FURTHER INVESTIGATION COULD BE PERFORMED. THE DEVICE HAS RETURNED TO SERVICE WITH NO SIMILAR ISSUES REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE TRANSESOPHAGEAL X8-2T TRANSDUCER WAS LEAKING FLUID FROM THE SCAN TIP. THE TRANSDUCER WAS ASSOCIATED WITH THE EPIQ CVX ULTRASOUND SYSTEM AT THE CUSTOMER'S SITE. THE ISSUE WAS DISCOVERED OUTSIDE OF CLINICAL USE. THERE WAS NO PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT. 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
    2782852 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