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

Model Number	G3 A20
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Codes	High Blood Pressure/ Hypertension (1908); Bronchial Hemorrhage (4456); Alteration in Body Temperature (4568); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	07/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer narrative: the device was returned to bmc for investigation and customer complaints were confirmed.When the reported malfunction occurred, the device emitted audible and visual alerts to notify the user that the device is unable to output the setting pressure, which triggers the inherent safety design of the device.The bmc inspection of the returned device found that after the device was powered on, a "77-03" (motor status abnormal) prompt appeared on the screen, and the device emitted a beeping sound.After disassembling the device for investigation, it was discovered that the surface-mount resistor rm37 on the pcba was broken, causing the fan fail to work properly.Eventually, the equipment was unable to output the setting pressure.The fracture of resistor rm37 is probably attributed to factors including: mechanical stress incurred during handling or use (e.G., impact), thermal stress during the pcb assembly process (e.G., soldering temperature excursions),an inherent latent defect within the component itself (e.G., micro-cracking),or a combination of these factors.Based on current post-market surveillance data, this failure mode is considered an isolated occurrence.As such, it is not presently classified as a systemic design-related issue.Bmc will continue to monitor field performance for similar events.Should future data indicate an increasing trend in the recurrence rate, a comprehensive re-evaluation will be promptly initiated, and appropriate engineering corrective actions will be implemented.
Event or Problem Description
React health received a complaint from a durable medical equipment provider that a patient stated his machine lost some power and he woke up several times with shortness of breath.His blood pressure was 181/101 (hypertensive crisis/urgency) and his hand was ice cold.The patient did not seek medical attention.The manufacturer has received the device and investigated.

• Brand Name: LUNA G3 APAP
• Common Device Name: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): BMC MEDICAL CO., LTD.; room 10, 17f, building 4,; huiya plaza, no.16 lize road; beijing, fengtai district CN 1 0007; CH CN 100073
• Manufacturer (Section G): BMC (TIANJIN) MEDICAL CO., LTD; 2/f north area and 3/f; blg no.4,no.1 xinxing road; wuqing district, tianjin CN 3 0179; CH CN 301799
• Manufacturer Contact: ning xu ; building c20,; venture headquarters base, no.18 fuyuan street; wuqing district, tianjin ; CH
• MDR Report Key: 23628032
• Report Number: 3008566132-2025-00001
• Device Sequence Number: 9536679
• Product Code: BZD
• UDI-Device Identifier: 06948538363331
• UDI-Public: (01)06948538363331(11)240801
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K201620
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/13/2025

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?: No
• Operator of Device: Lay User/Patient
• Device Model Number: G3 A20
• Device Catalogue Number: LG3600
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/12/2025
• Initial Report FDA Received Date: 11/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/01/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown