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

Model Number	LG3500
Medical Device Problem Codes	Leak/Splash (1354); Unexpected Shutdown (4019)
Health Effect - Clinical Code	Dyspnea (1816)
Date of Event	11/14/2023
Type of Reportable Event	Malfunction
Event or Problem Description
React health received a complaint from a durable medical equipment provider stating that the machine is blowing water straight out and causing a choking hazard to the patient.The equipment provider also stated the device was stopping during the night and the patient could not catch their breathe.No patient harm or injury has been reported.The manufacturer has received the device and investigated.
Additional Manufacturer Narrative
The device was returned to bmc for investigation.There were no abnormalities in the appearance and performance indicators of the device.Therefore, it is speculated that the adverse event was caused by the user's unexpected use.The investigation reasons are as follows: (1) device splashing problem: when the cpap is used along with the water chamber, if the water chamber is filled with water exceeding the max line, meanwhile the user does not wear the mask well and there is a large air leakage, the cpap operation flow monitoring value surpasses 150l/min, which results in a "splash effect" in a short period of time, and the water may flow into the tube and the mask.This circumstance is caused by unexpected use.(2) device suspension problem at night: if the user does not wear the mask well, there will be a large air leak, triggering the automatic shutdown of the device (when the auto off is turned on).The manufacturer has corresponding warning messages for the safe use of the equipment: following warnings are also provided in the user guide for the luna g3 cpap, 1.Make sure that the water does not exceed the maximum water level line.2.The device is not intended for life support.If there is any symptom of not being able to breathe, please stop using it immediately and seek for medical treatment promptly.

• Brand Name: LUNA G3 CPAP
• 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; fengtai district, beijing 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 ; 2/f north area and 3/f; blg no.4,no.1 xinxing road; wuqing district, tianjin CN 3-0179 ; CH CN 301799
• MDR Report Key: 19641512
• Report Number: 3008566132-2024-00012
• Device Sequence Number: 7065216
• Product Code: BZD
• UDI-Device Identifier: 06948538365625
• UDI-Public: (01)06948538365625(11)220125
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 07/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: LG3500
• Device Catalogue Number: LG3500
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/14/2023
• Initial Report FDA Received Date: 07/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/25/2022
• 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
• Patient Sex: Unknown