BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LUNA G3 APAP

    MDR report key: 23655384 · Received November 26, 2025

    Report

    Report Number
    3009096682-2025-00012
    Event Type
    Injury
    Date Received
    November 26, 2025
    Date of Event
    November 5, 2025
    Report Date
    April 17, 2026
    Manufacturer
    BMC MEDICAL CO., LTD
    Product Code
    BZD
    UDI-DI
    06948538363331
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    NC, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    3B MEDICAL, INC. DBA REACT HEALTH WAS CONTACTED BY A DURABLE MEDICAL EQUIPMENT (DME) PROVIDER ADVISING THAT THEIR PATIENT REPORTED THAT A LUNA G3 APAP MACHINE "BLEW A PIECE OF CHARCOAL DOWN HER THROAT AND SHE NOW COUGHS CHARCOAL". THE DEVICE HAS NOT BEEN RETURNED TO REACT HEALTH OR THE MANUFACTURER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2136911 LUNA G3 APAP VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD BMC MEDICAL CO., LTD G3-A20 N/A 06948538363331

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female