BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AFFINITI CVX ULTRASOUND SYSTEM

    MDR report key: 24317562 · Received February 11, 2026

    Report

    Report Number
    3019216-2026-100044
    Event Type
    Malfunction
    Date Received
    February 11, 2026
    Date of Event
    January 28, 2026
    Report Date
    February 11, 2026
    Manufacturer
    PHILIPS ULTRASOUND, INC
    Product Code
    IYN
    UDI-DI
    00884838126909
    PMA / PMN Number
    K132304
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    A CUSTOMER REPORTED THEIR AFFINITI CVX ULTRASOUND SYSTEM DISPLAYED COLOR DOPPLER ARTIFACT DURING A VASCULAR SURGERY. ANOTHER ULTRASOUND SYSTEM WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO USER OR PATIENT HARM AS A RESULT OF THE ISSUE. THE SERVICE ENGINEER CONFIRMED THE REPORTED PROBLEM AND REPLACED THE ACQUISITION BOARD TO ADDRESS 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
    374857 AFFINITI CVX ULTRASOUND SYSTEM SYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC IYN PHILIPS ULTRASOUND, INC 00884838126909

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown