BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LUNA G3 BPAP 25A

    MDR report key: 23265500 · Received October 10, 2025

    Report

    Report Number
    3009096682-2025-00010
    Event Type
    Injury
    Date Received
    October 10, 2025
    Date of Event
    September 1, 2024
    Report Date
    October 7, 2025
    Manufacturer
    BMC MEDICAL CO., LTD
    Product Code
    BZD
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED TO 3B MEDICAL, INC. DBA REACT HEALTH THAT A PATIENT ALLEGEDLY DEVELOPED A BURN ON THE BRIDGE OF HIS NOSE APPROXIMATELY TEN MONTHS TO A YEAR AGO ((B)(6) 2024). THE PATIENT ADVISED THAT HE WAS USING A RESMED AIRTOUCH N20 MASK, NOT A REACT HEALTH MASK. THE DEVICE HAS NOT BEEN RETURNED TO EITHER REACT HEALTH OR THE MANUFACTURER FOR AN EVALUATION. REACT HEALTH REACHED OUT TO THE PATIENT TO OBTAIN ADDITIONAL INFORMATION, AND HIS RESPONSES HAVE BEEN DOCUMENTED IN SECTION A. NO FURTHER DETAILS ABOUT THE PATIENT OR THE EVENT WERE PROVIDED. PAGE 20 OF THE LUNA G3 BPAP 25A USER MANUAL ADVISES THE FOLLOWING: ¿WARNINGS! - USE ONLY TUBING AND MASK PROVIDED BY REACT HEALTH.¿ [PLEASE NOTE: THE EVENT WAS REPORTED DIRECTLY TO REACT HEALTH BY THE PATIENT. AS A RESULT, SECTION E1 FIRST AND LAST NAME, AS WELL AS ADDRESS 1, SHALL BE LEFT BLANK AS IT IS PROTECTED HEALTH INFORMATION (PHI)]

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2113497 LUNA G3 BPAP 25A VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD BMC MEDICAL CO., LTD G3-B25A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male