BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EPIQ CVX DIAGNOSTIC ULTRASOUND SYSTEM

    MDR report key: 23408082 · Received October 28, 2025

    Report

    Report Number
    3019216-2025-000397
    Event Type
    Malfunction
    Date Received
    October 28, 2025
    Date of Event
    October 21, 2025
    Report Date
    December 15, 2025
    Manufacturer
    PHILIPS ULTRASOUND
    Product Code
    IYN
    UDI-DI
    00884838107526
    PMA / PMN Number
    K132304
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A QUALIFIED REMOTE SERVICE ENGINEER REVIEWED THE REPORTED PROBLEM WITH THE CUSTOMER¿S BIOMEDICAL ENGINEER AND THE ISSUE WAS CONFIRMED. THE BIOMEDICAL ENGINEER REPLACED THE TRANSDUCER TO RESOLVE THE CUSTOMER¿S IMMEDIATE CONCERN. THE ENGINEERING TEAM WAS UNABLE TO DETERMINE THE CAUSE OF THE REPORTED PROBLEM. AS THE CUSTOMER WOULD NOT RETURN THE TRANSDUCER AND PROVIDE OTHER PERTINENT INFORMATION REQUIRED FOR THE INVESTIGATION, NO FURTHER INVESTIGATION COULD BE PERFORMED. THE SYSTEM HAS RETURNED TO SERVICE WITH NO SIMILAR ISSUES REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE CUSTOMER THAT THE X7-8T TEE TRANSDUCER WOULD NOT ARTICULATE DURING USE WITH AN EPIQ CVX ULTRASOUND SYSTEM. THERE WAS NO PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT. THE CUSTOMER REQUESTED A REPLACEMENT TRANSDUCER TO RESOLVE THE CUSTOMER¿S ISSUES. AN INVESTIGATION IS UNDERWAY TO DETERMINE THE ROOT CAUSE OF THE ISSUE. RESULTS OF THE INVESTIGATION WILL BE INCLUDED IN A FOLLOW UP REPORT UPON ITS COMPLETION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236803 EPIQ CVX DIAGNOSTIC ULTRASOUND SYSTEM SYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC IYN PHILIPS ULTRASOUND 795231 00884838107526

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown