BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EPIQ CVX DIAGNOSTIC ULTRASOUND SYSTEM

    MDR report key: 23842096 · Received December 18, 2025

    Report

    Report Number
    3019216-2025-000492
    Event Type
    Malfunction
    Date Received
    December 18, 2025
    Date of Event
    December 11, 2025
    Report Date
    March 2, 2026
    Manufacturer
    PHILIPS ULTRASOUND
    Product Code
    IYN
    UDI-DI
    00884838107526
    PMA / PMN Number
    K251651
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A PHILIPS SERVICE ENGINEER CLEANED AND REASSEMBLED THE BUSHING (ACTUATOR) TO RESOLVE THE ISSUE. A THOROUGH ENGINEERING INVESTIGATION HAS BEEN PERFORMED TO IDENTIFY THE CAUSE OF THE REPORTED ISSUE. THE ENGINEERING TEAM DETERMINED THE FAILURE WAS EXCESSIVE GREASE APPLICATION IN THE ARTICULATING ARM.

    Description of Event or Problem · 0

    IT WAS REPORTED THE SWIVEL MECHANISM OF THE EPIQ CVX ULTRASOUND SYSTEM¿S CONTROL PANEL DID NOT LOCK PROPERLY WHILE TRANSPORTING THE UNIT WITHIN THE USER FACILITY. THE FAILURE OCCURRED OUTSIDE OF CLINICAL USE AND NO PATIENT OR USER WAS HARMED AS A RESULT OF THE ISSUE. A PHILIPS FIELD SERVICE ENGINEER DISASSEMBLED AND CLEANED THE SOLENOID TO RESOLVE THE CUSTOMER¿S IMMEDIATE CONCERNS. 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
    1145 EPIQ CVX DIAGNOSTIC ULTRASOUND SYSTEM SYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC IYN PHILIPS ULTRASOUND 795231 00884838107526

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown