BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LUNA G3 APAP

    MDR report key: 24241125 · Received February 2, 2026

    Report

    Report Number
    3009096682-2026-00002
    Event Type
    Injury
    Date Received
    February 2, 2026
    Date of Event
    January 3, 2026
    Report Date
    February 2, 2026
    Manufacturer
    BMC MEDICAL CO., LTD
    Product Code
    BZD
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    3B MEDICAL, INC. DBA REACT HEALTH WAS CONTACTED THROUGH THE REACT HEALTH MOBILE APP SUPPORT, BY A PATIENT THAT THEY FELT TOO MUCH PRESSURE THROUGH THE NIGHT AND COULD NOT WEAR THE MASK CONTINUOUSLY. THEY FELT THEIR EYES WATER, THAT IT WAS GIVING THEM A HEADACHE, AND IT WAS DIFFICULT TO BREATHE DUE TO TOO MUCH PRESSURE BLOWING IN THEIR FACE. NO FURTHER DETAILS ABOUT THE PATIENT OR THE EVENT WAS PROVIDED. 3B MEDICAL INC HAS MADE MULTIPLE ATTEMPTS THROUGH EMAIL AND A PHONE NUMBER THAT WAS FOUND ON THE INTERNET, TO CONTACT THE PATIENT IN ORDER TO OBTAIN ADDITIONAL INFORMATION ABOUT IF THERE WAS ANY HARM TO THE PATIENT AND DETAILS OF THE EVENT, BUT NO FURTHER INFORMATION HAS BEEN PROVIDED. 3B MEDICAL, INC. IS REPORTING THIS EVENT OUT OF AN ABUNDANCE OF CAUTION. THE PATIENT CONTACTED 3B MEDICAL INC DIRECTLY, AS A RESULT, SECTION E1 NAME, ADDRESS AND PHONE ARE ALL NA TO PROTECT THEIR PRIVACY. THE DEVICE HAS NOT BEEN RETURNED TO 3B MEDICAL INC OR THE MANUFACTURER FOR AN EVALUATION. THE CAUSE OF THE REPORTED ISSUE COULD NOT BE DETERMINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    294475 LUNA G3 APAP VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD BMC MEDICAL CO., LTD LG3600 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown