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

Model Number	LG3800
Medical Device Problem Codes	Mechanical Problem (1384); Off-Label Use (1494)
Health Effect - Clinical Code	Low Oxygen Saturation (2477)
Date of Event	05/08/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
According to the importer's description, the patient was 31 months old and weighed 31 pounds.The luna g3 bpap includes the following instructions in the instruction manual.1.The device is intended for adult patients weighing more than 66 lbs (30 kg) by prescription.2.This device is not intended for life support.The manufacturer currently believes that this patient is not the intended population for the device, which may have contributed to the reported event.The manufacturer has asked the importer to return the device for analysis and investigation.After the device is returned to analyze and locate the cause, the follow-up report will be carried out.
Event or Problem Description
React health received a complaint from a durable medical equipment provider that a device shut off while on a patient in the hospital.The patient experienced oxygen destaturation and was placed on oxygen and recovered on their own.The patient was placed on an alternative device.The device was being used off label per published intended use.The device is intended for adult patients weighing more than 66 lbs (30 kg) with sufficient respiratory drive.It is not intended for life support.The device has not been returned to the importer.

• Brand Name: LUNA G3 BPAP
• 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 ; building c20,; venture headquarters base, no.18 fuyuan street; wuqing district, tianjin CN 3-0179 ; CH CN 301799
• MDR Report Key: 19640665
• Report Number: 3008566132-2024-00016
• Device Sequence Number: 8793118
• Product Code: BZD
• UDI-Device Identifier: 06948538365731
• UDI-Public: (01)06948538365731(11)220525
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K212263
• 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): 06/30/2024

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: LG3800
• Device Catalogue Number: LG3800
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/27/2024
• Initial Report FDA Received Date: 06/29/2024
• Was Device Evaluated by Manufacturer? (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: Required Intervention
• Patient Age: 31 MO
• Patient Sex: Male
• Patient Weight: 14 KG