BEUDAMED
    FDA Adverse Event Death Summary report: N

    CX50

    MDR report key: 22685695 · Received August 1, 2025

    Report

    Report Number
    3019216-2025-000268
    Event Type
    Death
    Date Received
    August 1, 2025
    Date of Event
    July 23, 2025
    Report Date
    September 11, 2025
    Manufacturer
    PHILIPS ULTRASOUND, INC
    Product Code
    IYN
    PMA / PMN Number
    K081802
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A THOROUGH INVESTIGATION WAS PERFORMED TO DETERMINE IF THE SYSTEM MALFUNCTIONED. THE SYSTEM LOGS WERE REVIEWED AND ONLY A DISCONNECTED NETWORK CABLE WAS NOTED IN THE LOGS. THIS ISSUE WOULD NOT AFFECT THE IMAGE QUALITY OR THE PERFORMANCE OF THE SYSTEM. THE USER WOULD STILL BE ABLE TO OBTAIN IMAGES AS WELL AS MEASUREMENTS AND CALCULATIONS. THERE WAS NO ALLEGATION OR EVIDENCE OF A MALFUNCTION OF THE DEVICE. NO FURTHER INFORMATION COULD BE OBTAINED FROM THE CUSTOMER.

    Description of Event or Problem · 0

    A CUSTOMER REPORTED A PATIENT HAD EXPIRED THE SAME DAY THEIR CX50 ULTRASOUND SYSTEM WAS USED UPON THEM. NO FURTHER INFORMATION WAS PROVIDED NOR COULD BE OBTAINED AT THIS TIME. THE SERVICE ENGINEER REPORTED THE SYSTEM AND TRANSDUCER TESTING PASSED AND THE SYSTEM WAS FULLY OPERATIONAL AND FUNCTIONAL. 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
    213194 CX50 SYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC IYN PHILIPS ULTRASOUND, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death