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

Model Number	LG2A00
Medical Device Problem Code	Device Emits Odor (1425)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/17/2023
Type of Reportable Event	Malfunction
Event or Problem Description
React health received a complaint from a durable medical equipment provider stating their patient reports a burning odor while using the cpap.There was no patient injury or harm reported.The manufacturer has received the device and investigated.
Additional Manufacturer Narrative
The device was returned to bmc for investigation, which resulted in the following: 1.The device is running normally.No burning smell can be detected at the air outlet, but perfume or aromatherapy smell can be detected.2.After disassembling the device, the whole device and gas path components do not smell the burning smell, but can smell the perfume or aromatherapy smell.At the same time, it is found that this device uses filter that is not provided by the manufacturer, and the size is not appropriate.As a result, the filter and the filter box do not match to achieve the expected sealing effect of the device, and the internal dirt and dust of the anti-friction box are found.Therefore, the sources of burning odor feedback from customers may have the following two possibilities: (1) odor caused by cleaning agent residue or introduced by external environment; (2) odor introduced by the use of filter cotton not provided by the manufacturer; the manufacturer has warning information about the misuse of accessories: the luna ii auto user manual also provides warnings." to ensure that you receive the safe, effective therapy prescribed for you, use only the manufacturer accessories.".

• Brand Name: LUNA II AUTO
• 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: 19791792
• Report Number: 3008566132-2024-00013
• Device Sequence Number: 19883239
• Product Code: BZD
• UDI-Device Identifier: 06948538363294
• UDI-Public: (01)06948538363294(11)220721
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K153387
• 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): 12/15/2023

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: LG2A00
• Device Catalogue Number: LG2A00
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/15/2023
• Initial Report FDA Received Date: 07/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/21/2022
• 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