BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LUNA G3 BPAP 25A

    MDR report key: 24773853 · Received April 3, 2026

    Report

    Report Number
    3008566132-2026-00003
    Event Type
    Injury
    Date Received
    April 3, 2026
    Date of Event
    February 16, 2026
    Report Date
    May 22, 2026
    Manufacturer
    BMC MEDICAL CO., LTD.
    Product Code
    BZD
    UDI-DI
    06948538365649
    PMA / PMN Number
    K213169
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    BMC RECEIVED A REPORT SUBMITTED BY IMPORTER REACT HEALTH. IT WAS REPORTED TO 3B MEDICAL, INC. DBA REACT HEALTH THAT A COMPLAINT WAS RECEIVED FROM A DURABLE MEDICAL EQUIPMENT PROVIDER INDICATING THAT THE CPAP'S PRESSURES WERE SWINGING AND THE USAGE REPORT INDICATED IRREGULARITIES. THE PATIENT WAS ADMITTED TO THE HOSPITAL DUE TO THE MALFUNCTION ON APPROXIMATELY (B)(6) 2026 FOR BREATHING ISSUES, ACCORDING TO THE DME. THE PATIENT HAS DISCONTINUED USING THIS DEVICE AND ANOTHER WAS ISSUED FROM THE DME'S STOCK. IT IS NOT KNOWN WHAT THE PATIENT'S CURRENT STATUS IS, AND PATIENT HISTORY INCLUDING PREEXISTING MEDICAL CONDITIONS WERE NOT PROVIDED; HOWEVER, SHE HAS BEEN DISCHARGED FROM THE HOSPITAL AND IS BACK HOME. 3B MEDICAL, INC. HAS RECEIVED THE DEVICE FOR EVALUATION AND IT WILL BE SENT 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
    21721 LUNA G3 BPAP 25A VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD BMC MEDICAL CO., LTD. LG3700 06948538365649

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Female Hospitalization