BEUDAMED
    FDA Adverse Event Death Summary report: N

    LUMIFY DIAGNOSTIC ULTRASOUND SYSTEM

    MDR report key: 23496802 · Received November 7, 2025

    Report

    Report Number
    3019216-2025-000427
    Event Type
    Death
    Date Received
    November 7, 2025
    Date of Event
    October 9, 2025
    Report Date
    May 7, 2026
    Manufacturer
    PHILIPS ULTRASOUND, INC
    Product Code
    IYN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION WAS PERFORMED, INCLUDING MANUAL REPRODUCTION TESTING USING ANOTHER DEVICE TO IDENTIFY THE CAUSE OF THE REPORTED ISSUE. THE ENGINEERING TEAM DETERMINED THAT THE TRANSDUCER USB-C CONNECTOR CAN EXHIBIT REDUCED MECHANICAL RETENTION WHEN MATED TO THE TABLET PORT. THIS CAN LEAD TO AN INTERMITTENT ISSUE WHERE THE FIRMWARE VERSION IS UNRECOGNIZED. WHEN THIS OCCURS A PROMPT TO REREGISTER THE TRANSDUCER IS DISPLAYED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE LUMIFY ULTRASOUND SYSTEM WAS NOT AVAILABLE DURING AN EMERGENT ECMO (EXTRA-CORPOREAL MEMBRANE OXYGENATION) BECAUSE THE TRANSDUCER WAS NOT REGISTERED TO THE SYSTEM, WHICH RESULTED IN A PATIENT DEATH. ADDITIONAL INFORMATION IS BEING OBTAINED. 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
    11015 LUMIFY DIAGNOSTIC ULTRASOUND SYSTEM SYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC IYN PHILIPS ULTRASOUND, INC 989605449841

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death