BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LUNA G3 APAP

    MDR report key: 22936226 · Received September 2, 2025

    Report

    Report Number
    3009096682-2025-00008
    Event Type
    Injury
    Date Received
    September 2, 2025
    Date of Event
    July 29, 2025
    Report Date
    December 10, 2025
    Manufacturer
    BMC MEDICAL CO., LTD
    Product Code
    BZD
    UDI-DI
    06948538365892
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    CORRECTED INFORMATION FOR SUPPLEMENTAL MEDWATCH REPORT 001 ¿ SECTION B5, DESCRIBE EVENT OR PROBLEM, OF THE INITIAL MEDWATCH REPORT STATED: REACT HEALTH RECEIVED A COMPLAINT FROM A DURABLE MEDICAL EQUIPMENT PROVIDER THAT A PATIENT STATED THE PRESSURE ON HIS UNIT WAS VERY STRONG, GIVING HIM CHEST PAINS. THE PATIENT DID NOT SEEK MEDICAL ATTENTION, AND THE EVENT OF CHEST PAINS RESOLVED. THE DEVICE WAS RETURNED TO THE IMPORTER AND DURING INVESTIGATION, A FAULTY FLOW SENSOR WAS DETERMINED TO BE THE CAUSE OF THE HIGH PRESSURE. THE MANUFACTURER HAS NOT TAKEN POSSESSION OF THE DEVICE AS OF THIS REPORT. SECTION B5, DESCRIBE EVENT OR PROBLEM, OF THE INITIAL MEDWATCH REPORT SHOULD HAVE STATED: A DURABLE MEDICAL EQUIPMENT (DME) PROVIDER CONTACTED 3B MEDICAL, INC. (DBA REACT HEALTH) TO REPORT THAT A PATIENT STATED THE PRESSURE BEING DELIVERED BY HIS DEVICE WAS VERY STRONG, GIVING HIM CHEST PAINS. THE PATIENT DID NOT SEEK MEDICAL ATTENTION, AND THEIR CHEST PAINS RESOLVED. THE DEVICE WAS RETURNED TO THE IMPORTER FOR EVALUATION. REACT HEALTH EXAMINED THE DEVICE AND SUSPECTED THAT THE LIKELY CAUSE OF THE REPORTED ISSUE WAS THE FLOW SENSOR. THE DEVICE WILL BE FORWARDED TO THE MANUFACTURER, BMC MEDICAL CO., LTD, FOR AN EVALUATION. SECTION F10, ADVERSE EVENT PROBLEM - HEALTH EFFECT CLINICAL CODE, OF THE INITIAL MEDWATCH REPORT STATED: E2330 (PAIN) AND E2402 (APPROPRIATE TERM/CODE NOT AVAILABLE) SECTION F10, ADVERSE EVENT PROBLEM - HEALTH EFFECT CLINICAL CODE, OF THE INITIAL MEDWATCH REPORT SHOULD HAVE ONLY STATED: E2330 (PAIN). SECTION F10, ADVERSE EVENT PROBLEM - HEALTH EFFECT IMPACT CODE, OF THE INITIAL MEDWATCH REPORT STATED: F24 (INSUFFICIENT INFORMATION) SECTION F10, ADVERSE EVENT PROBLEM - HEALTH EFFECT IMPACT CODE, OF THE INITIAL MEDWATCH REPORT SHOULD HAVE STATED: F11 (MINOR INJURY/ ILLNESS / IMPAIRMENT). SECTION F10, ADVERSE EVENT PROBLEM ¿ MEDICAL DEVICE PROBLEM CODE, OF THE INITIAL MEDWATCH REPORT STATED: A24 (ADVERSE EVENT WITHOUT IDENTIFIED DEVICE OR USE PROBLEM) AND A141102 (INCREASE IN PRESSURE) SECTION F10, ADVERSE EVENT PROBLEM ¿ MEDICAL DEVICE PROBLEM CODE, OF THE INITIAL MEDWATCH REPORT ONLY STATED: A141102 (INCREASE IN PRESSURE). SECTION F10, ADVERSE EVENT PROBLEM ¿ COMPONENT CODE, OF THE INITIAL MEDWATCH REPORT STATED: G0301204 (PRESSURE SENSOR) SECTION F10, ADVERSE EVENT PROBLEM ¿ COMPONENT CODE, OF THE INITIAL MEDWATCH REPORT STATED: G07003 (INSUFFICIENT INFORMATION). NEW INFORMATION FOR SUPPLEMENTAL MEDWATCH REPORT 001 ¿ F10: THE DEVICE WAS RETURNED TO THE MANUFACTURER, BMC MEDICAL CO., LTD (¿BMC¿), FOR AN EVALUATION. BMC PROVIDED THE IMPORTER, 3B MEDICAL, INC. (DBA REACT HEALTH), WITH THE FOLLOWING DEVICE EVALUATION REPORT: ¿INVESTIGATION: 1. SUMMARIZE: THIS DEVICE HAS BEEN USED FOR TREATMENT. THE MANUFACTURER (BMC) HAS CONTACTED THE IMPORTER (REACT HEALTH) AND REQUESTED THAT THE IMPORTER RETURN THE DEVICE FOR FURTHER INVESTIGATION AND ANALYSIS. BMC HAS INITIATED A BATCH RECORD TRACE: PRODUCTION ORDER NUMBER BMC-JY-E2306091-A-6, PRODUCTION DATE AUGUST 6, 2023, WAREHOUSING DATE AUGUST 7, 2023, QUANTITY 470 UNITS, INSPECTION PASSED.¿ ¿PRODUCT PERFORMANCE INSPECTION REPORT: ON SEPTEMBER 18, 2025, BMC HAS RECEIVED THE DEVICE AND IS CONDUCTING AN ANALYSIS.¿ ¿2. WHETHER THE PRODUCT HAS BEEN USED FOR THERAPEUTIC OR DIAGNOSTIC PURPOSES YES ¿ THE PRODUCT HAS BEEN USED FOR TREATMENT¿. ¿3. WHETHER THE DEVICE IS WORKING PROPERLY: YES, IF YES, INDICATE THE CURRENT USAGE TIME) 3842 HOUR¿. "ANALYSIS OF CAUSES: 1. WHETHER THE PROBLEMS COMPLAINED OF IN THE CUSTOMER COMPLAINT ARE TRUE: OTHER-THE EQUIPMENT HAS BEEN RE-INSPECTED AND ALL PERFORMANCE INDICATORS ARE QUALIFIED". "2. ANALYSIS PROCESS: THE DEVICE CAN ENTER THE STARTUP INTERFACE NORMALLY WHEN POWERED ON. CHECK THE USER SETTINGS. THERE HAVE BEEN NO PARAMETER MODIFICATIONS IN THE PAST MONTH. AMONG THEM, THE RAMP TIME WAS SET TO 10 MINUTES FOR THE PATIENT'S USE, BUT LATER IT WAS CHANGED TO OFF BY RH AFTER TESTING. BY REVIEWING THE HISTORICAL USAGE OF THE PATIENT'S DEVICE THROUGH THE SD CARD DATA, IT WAS FOUND THAT THE DEVICE HAS BEEN OPERATING NORMALLY. ANALYZING THE DETAILED USAGE DATA OF THE PATIENT, NO ABNORMAL USAGE DATA WAS FOUND. THE DATA RECORDS OF THE FLOW SENSOR AND PRESSURE SENSOR WERE NORMAL. THE EQUIPMENT WAS SUBJECTED TO STATIC PRESSURE TESTS (0 LPM, 20 LPM, 65 LPM, 90 LPM). THE PRESSURE AT THE END OF THE PIPELINE WAS NORMAL, AND THE FLOW ACCURACY WAS ALSO NORMAL. (ACCORDING TO THE PATIENT'S USAGE DATA, THE FLOW RATE DURING THE PATIENT'S USAGE PROCESS WAS APPROXIMATELY 65 LPM.). ANALYZING THE USAGE DATA OF THE NIGHT BEFORE THE PATIENT REPORTED THE PROBLEM, THE POINTS WITH HIGHER PRESSURE COLLECTION AT THE DEVICE END ALL OCCURRED AT THE LOCATIONS OF LARGE AIR LEAKS. THESE WERE NORMAL AIR LEAKAGE COMPENSATION ACTIONS OF THE EQUIPMENT, AND THE PRESSURE AT THE PATIENT END WAS NORMAL. IN CONCLUSION, BASED ON THE SD DATA ANALYSIS, THE EQUIPMENT IS OPERATING NORMALLY. INTERNAL INSPECTION: THE LOWER SHELL WAS REMOVED AND THE MACHINE WAS INSTALLED NORMALLY. THERE IS NO WATER INGRESS IN THE FLOW SENSOR. THE PRESSURE SENSOR IS NORMAL." "3. CONCLUSION OF ANALYSIS: THROUGH THE ANALYSIS OF THE USER USAGE DATA OF THE SD CARD, IT WAS FOUND THAT THE DATA DISPLAYED BY BOTH THE FLOW SENSOR AND THE PRESSURE SENSOR WERE NORMAL. THE POINTS WHERE THE PRESSURE COLLECTION AT THE DEVICE END IS RELATIVELY HIGH ARE ALL LOCATED AT THE POSITIONS WITH LARGE AIR LEAKAGE (WHICH MAY BE CAUSED BY THE MASK NOT BEING WORN PROPERLY OR THE USER REMOVING THE MASK). WHEN THE DEVICE DETECTS A LARGE AIR LEAKAGE, IT AUTOMATICALLY PERFORMS PRESSURE COMPENSATION TO ENSURE THAT THE PRESSURE AT THE PATIENT END CAN REACH THE SET PRESSURE OF THE USER.¿ ¿STATIC PRESSURE TESTS WERE CONDUCTED ON THE EQUIPMENT, AND THE RESULTS SHOWED THAT THE PRESSURE AT THE END OF THE PIPELINE WAS NORMAL, AND THE FLOW RATE DETECTED BY THE EQUIPMENT WAS CONSISTENT WITH THAT OF THE FLOWMETER. BASED ON THE SD CARD DATA OF THE DEVICE AND THE TEST DATA OF THE DEVICE, AN OBJECTIVE ANALYSIS WAS CONDUCTED. THERE ARE NO ABNORMALITIES IN THE DEVICE ITSELF. THE CHEST PAIN SYMPTOMS REPORTED BY USERS MAY BE CAUSED BY OTHER FACTORS.¿ ¿BASED ON ALL AVAILABLE EVIDENCE, THE INVESTIGATION DETERMINED THAT THE LG3600 VENTILATOR MEETS THE SPECIFICATION REQUIREMENTS AND THE USAGE RISK OF THE EQUIPMENT REMAINS WITHIN AN ACCEPTABLE RANGE." THE MANUFACTURER, BMC, WAS UNABLE TO IDENTIFY ANY DEVICE ISSUES WHICH MAY HAVE CONTRIBUTED TO THE PATIENTS ALLEGED CHEST PAINS. THE CAUSE OF THE REPORTED ISSUE COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    REACT HEALTH RECEIVED A COMPLAINT FROM A DURABLE MEDICAL EQUIPMENT PROVIDER THAT A PATIENT STATED THE PRESSURE ON HIS UNIT WAS VERY STRONG, GIVING HIM CHEST PAINS. THE PATIENT DID NOT SEEK MEDICAL ATTENTION, AND THE EVENT OF CHEST PAINS RESOLVED. THE DEVICE WAS RETURNED TO THE IMPORTER AND DURING INVESTIGATION, A FAULTY FLOW SENSOR WAS DETERMINED TO BE THE CAUSE OF THE HIGH PRESSURE. THE MANUFACTURER HAS NOT TAKEN POSSESSION OF THE DEVICE AS OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136058 LUNA G3 APAP VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD BMC MEDICAL CO., LTD G3-A20 N/A 06948538365892

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown