BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LUMIFY DIAGNOSTIC ULTRASOUND SYSTEM

    MDR report key: 23711365 · Received December 3, 2025

    Report

    Report Number
    3019216-2025-000460
    Event Type
    Injury
    Date Received
    December 3, 2025
    Date of Event
    November 29, 2022
    Report Date
    May 5, 2026
    Manufacturer
    PHILIPS ULTRASOUND, INC
    Product Code
    IYN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION WAS PERFORMED, HOWEVER THERE WAS INSUFFICIENT INFORMATION TO DETERMINE CAUSE OF THE REPORTED ISSUE. ESSENTIAL INFORMATION SUCH AS THE PHYSICAL DEVICE, LOGS, OR STEPS TO REPRODUCE THE ISSUE WERE NOT PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THE LUMIFY ULTRASOUND SYSTEM WAS NOT AVAILABLE DURING A CRITICAL PROCEDURE. THE ULTRASOUND SYSTEM GENERATED AN ERROR CODE DURING EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO). THE ULTRASOUND SYSTEM WAS EXCHANGED TO COMPLETE THE PROCEDURE. ADDITIONAL INFORMATION IS BEING OBTAINED TO DETERMINE PATIENT OUTCOME. 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
    445534 LUMIFY DIAGNOSTIC ULTRASOUND SYSTEM SYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC IYN PHILIPS ULTRASOUND, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention