BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LUNA G3 BPAP SYSTEM

    MDR report key: 24320642 · Received February 12, 2026

    Report

    Report Number
    3008566132-2026-00002
    Event Type
    Injury
    Date Received
    February 12, 2026
    Date of Event
    December 13, 2025
    Report Date
    April 1, 2026
    Manufacturer
    BMC MEDICAL CO., LTD.
    Product Code
    BZD
    UDI-DI
    06948538365731
    PMA / PMN Number
    K213169
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER CONDUCTED AN ENGINEERING INVESTIGATION AFTER RECEIVING THE DEVICE. THE RESULTS OF THE INVESTIGATION ARE AS FOLLOWS: 1. THE LUNA G3 BPAP SYSTEM IS A BI-LEVEL PAP (BI-LEVEL POSITIVE AIRWAY PRESSURE) DEVICE DESIGNED FOR THE TREATMENT OF ADULT OBSTRUCTIVE SLEEP APNEA (OSA). THE DEVICE IS INDICATED FOR USE AND FDA CLEARED FOR ADULT PATIENTS > 66 LBS / 30 KG FOR WHOM CPAP THERAPY HAS BEEN PRESCRIBED. THE PATIENT MENTIONED IN (B)(6) IS 15 YEARS OLD AND IS OUTSIDE THE POPULATION OF THE DEVICE INDICATION OF USE. 2.FROM REVIEWING THE SD CARD DATA OF THE DEVICE AND TESTING THE RETURNED DEVICE (B)(6), IT WAS OBSERVED THAT WHEN THE TARGET TIDAL VOLUME WAS NOT REACHED, THE INSPIRATORY PRESSURE CONTINUED TO RISE UNTIL IT REACHED THE MAX IPAP(26HPA); WHEN THE TARGET TIDAL VOLUME WAS REACHED AND MAINTAINED, THE INSPIRATORY PRESSURE WOULD BE LOWER THAN THE MAX IPAP PART OF THE TIME. THE DEVICE IS PERFORMING AS DESIGNED.

    Additional Manufacturer Narrative · 0

    BMC HAS REQUESTED THE IMPORTER TO RETURN THE DEVICE SO THAT A FULL ENGINEERING ANALYSIS CAN BE CONDUCTED. CURRENTLY, BMC HAS OBTAINED THE REACT HEALTH CONNECT DATA AND SD CARD USAGE DATA FROM THE DEVICE AND IS CONDUCTING THE ANALYSIS. ONCE THE DEVICE IS RETURNED TO THE BMC IN THE NEAR FUTURE, A COMPREHENSIVE ENGINEERING ANALYSIS WILL BE COMPLETED BY COMBINING THE AFOREMENTIONED USAGE DATA, AND THE BMC WILL SUBMIT A SUPPLEMENTAL REPORT THEREAFTER.

    Description of Event or Problem · 0

    BMC RECEIVED A REPORT SUBMITTED BY IMPORTER REACT HEALTH. THE CONTENT IS AS FOLLOWS: 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
    219132 LUNA G3 BPAP SYSTEM VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD BMC MEDICAL CO., LTD. LG3800-30VT 06948538365731

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Female Hospitalization