BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AFFINITI CVX DIAGNOSTIC ULTRASOUND SYSTEM

    MDR report key: 24062573 · Received January 13, 2026

    Report

    Report Number
    3019216-2026-100008
    Event Type
    Malfunction
    Date Received
    January 13, 2026
    Date of Event
    December 15, 2025
    Report Date
    January 13, 2026
    Manufacturer
    PHILIPS ULTRASOUND, INC
    Product Code
    IYN
    UDI-DI
    00884838126909
    PMA / PMN Number
    K132304
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SWIVEL MECHANISM OF THE AFFINITI 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. NO FURTHER INFORMATION IS AVAILABLE. 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
    121562 AFFINITI CVX DIAGNOSTIC ULTRASOUND SYSTEM SYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC IYN PHILIPS ULTRASOUND, INC 795190 00884838126909

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown