BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BILISOFT 2.0

    MDR report key: 23943066 · Received January 2, 2026

    Report

    Report Number
    23943066
    Event Type
    Malfunction
    Date Received
    January 2, 2026
    Date of Event
    October 12, 2025
    Report Date
    November 24, 2025
    Manufacturer
    LUMITEX MEDICAL DEVICES, INC
    Product Code
    LBI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    ID
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    ON [REDACTED], DURING PATIENT CARE, THE RN NOTED A BURNING SMELL IN THE ROOM. THE RN PROMPTLY INVESTIGATED AND NOTED THAT THE SMELL EMANATED FROM THE BILISOFT 2.0 PHOTOTHERAPY BLANKET BOX. THE RN TURNED OFF THE PHOTOTHERAPY LIGHT AND INSPECTED THE DEVICE. UPON INSPECTION, SIGNS OF BURNING METAL WERE OBSERVED WITHIN THE DEVICE, SPECIFICALLY AT THE FIBER OPTIC CONNECTION POINT OF THE CORD NEAR THE BOX. THE DEVICE WAS PROMPTLY REMOVED FROM USE AND SEQUESTERED. A REPLACEMENT DEVICE WAS UTILIZED WITHOUT DELAY, AND NO HARM OCCURRED TO THE PATIENT. NO DEVIATION FROM INTENDED PROCEDURE. PHOTOTHERAPY BLANKET HAD BEEN FUNCTIONING CORRECTLY, AND STAFF HAD CONFIRMED IRRADIANCE LEVELS WERE APPROPRIATE FOR THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2517 BILISOFT 2.0 UNIT, NEONATAL PHOTOTHERAPY LBI LUMITEX MEDICAL DEVICES, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 3 DA Female