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

Model Number	LG3600
Medical Device Problem Code	Device Emits Odor (1425)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
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 pressure was pulsing and the device was emitting a burning smell.No patient harm or injury was reported.The device has not been returned to the importer.A follow up report will be filed once the investigation is complete.
Additional Manufacturer Narrative
The manufacturer has requested the distributor to return the machine for analysis and investigation.The machine has not been returned yet, and the manufacturer cannot determine whether the problem is caused by improper user use or equipment malfunction.After the machine is returned to the manufacturer, analyze and locate the cause.

• 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; 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 0170; CH CN 301700
• Manufacturer Contact: ning xu ; building c20; venture headquarters base, no.18 fuyuan street; wuqing district, tianjin CN 3-0170 ; CH CN 301700
• MDR Report Key: 19398863
• Report Number: 3008566132-2024-00003
• Device Sequence Number: 7800221
• Product Code: BZD
• UDI-Device Identifier: 06948538363331
• UDI-Public: (01)06948538363331(11)230308
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 05/26/2024

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: LG3600
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/13/2023
• Initial Report FDA Received Date: 05/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/08/2023
• 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