BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LUMIFY DIAGNOSTIC ULTRASOUND SYSTEM

    MDR report key: 23744402 · Received December 8, 2025

    Report

    Report Number
    3019216-2025-000474
    Event Type
    Injury
    Date Received
    December 8, 2025
    Date of Event
    March 1, 2024
    Report Date
    May 7, 2026
    Manufacturer
    PHILIPS ULTRASOUND, INC
    Product Code
    IYN
    PMA / PMN Number
    K162549
    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 AN EMERGENT EXAMINATION OF A PATIENT WITH CHEST TRAUMA. THE ULTRASOUND SYSTEM GENERATED AN ERROR CODE AND THE EXAM WAS SUBSEQUENTLY ABORTED. 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
    211611 LUMIFY DIAGNOSTIC ULTRASOUND SYSTEM SYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC IYN PHILIPS ULTRASOUND, INC 795005

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention