BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LUNA G3 BPAP 30VT

    MDR report key: 24319181 · Received February 11, 2026

    Report

    Report Number
    3009096682-2026-00003
    Event Type
    Injury
    Date Received
    February 11, 2026
    Date of Event
    December 13, 2025
    Report Date
    February 11, 2026
    Manufacturer
    BMC MEDICAL CO., LTD
    Product Code
    BZD
    UDI-DI
    06948538365731
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    NE, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED TO 3B MEDICAL, INC. DBA REACT HEALTH, THAT A PATIENT WAS ADMITTED TO THE HOSPITAL FOR A ¿COLLAPSED LUNG¿, WHICH WAS POTENTIALLY DUE TO THE LUNA G3 BPAP ¿UNDER VENTILATING.¿ ACCORDING TO THE DURABLE MEDICAL EQUIPMENT (DME) PROVIDER, THE PATIENT HAD BEEN USING THIS DEVICE FOR 18 DAYS WHILE RECEIVING THERAPY AT HOME. ON (B)(6) 2025 THE PATIENT WAS ADMITTED TO AN OUTSIDE HOSPITAL FOR ACUTE CHRONIC RESPIRATORY FAILURE. THE PATIENT¿S CONDITION HAS SINCE RESOLVED, AND THEY HAVE BEEN TRANSITIONED TO A RESMED DEVICE FOR SUPPORT. 3B MEDICAL, INC., HAS REQUESTED THAT THE DEVICE BE RETURNED FOR AN EVALUATION, HOWEVER, THE CUSTOMER STATED THAT THEY WILL NOT BE RETURNING THE DEVICE AT THIS TIME. 3B MEDICAL, INC., HAS SENT THE REACT HEALTH CONNECT DATA FROM THE DEVICE TO THE MANUFACTURER, BMC MEDICAL CO., LTD (¿BMC¿), FOR ANALYSIS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE AS DEFINED BY 21 CFR 803.56.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    377036 LUNA G3 BPAP 30VT VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD BMC MEDICAL CO., LTD G3-B30VT 06948538365731

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Female Hospitalization