MAUDE Adverse Event Report: BMC MEDICAL CO., LTD LUNA G3 APAP; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number	G3-A20
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Codes	Dyspnea (1816); High Blood Pressure/ Hypertension (1908)
Date of Event	09/22/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
3b medical, inc.Dba react health was contacted by a durable medical equipment (dme) provider advising that their patient reported that over the last few weeks he's been waking up with increased blood pressure and "feelings of suffocation¿ using the device.The dme provider advised react health that he had reviewed the data from the patient¿s device and noticed increases in pressure, but there were no apparent obstructions occurring (or at least nothing being recorded by the device).Additionally, he advised that the leak level was showing no deviation at all ¿ it was at 0.The device was then returned to, and evaluated by, react health who verified the reported issues that the device was increasing in pressure and that the data was not being recorded.During testing, react health also observed that the flow was abnormally low.React health determined that the root cause of the reported issues was the flow sensor on the main pcba.The device has not been returned to the manufacturer.

• Brand Name: LUNA G3 APAP
• Common Device Name: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): BMC MEDICAL CO., LTD; room 110 tower a fengyu bldg; no.115 fucheng road; haidian, beijing 10003 6; CH 100036
• MDR Report Key: 23326312
• Report Number: 3009096682-2025-00011
• Device Sequence Number: 10616755
• Product Code: BZD
• UDI-Device Identifier: 06948538363331
• UDI-Public: (01)06948538363331(11)241220
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Report Source: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/17/2025
• Report Date (Section F): 10/17/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: G3-A20
• Device Catalogue Number: LG3600
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 09/22/2025
• Device Age: 9 MO
• Event Location: Home
• Date Report to Manufacturer: 10/17/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/17/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Age: 43 YR
• Patient Sex: Male
• Patient Weight: 137 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White
• Date Report Sent to FDA: 10/17/2025