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

Model Number	B25A
Medical Device Problem Code	Thermal Decomposition of Device (1071)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/29/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned to bmc for investigation and customer complaints were confirmed.There is evidence that the air inlet part of the device and the filter have been burnt, and there is a large area of thermal damage on the external surface of the device.The circuit board and fan are normal and there is no thermal damage.The manufacturer believes that the thermal damage occurred due to an unknown external fire source near the air intake of the equipment and user abuse, rather than due to device failure.Based on the available information, the manufacturer concludes no further action is necessary.There was no patient harm or injury reported.
Event or Problem Description
(b)(6) received a complaint from a durable medical equipment provider that a bpap had burn marks on the side and back.No patient harm or injury was reported.The manufacturer has received the device and investigated.

• 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: 19805908
• Report Number: 3008566132-2024-00017
• Device Sequence Number: 7524825
• Product Code: BZD
• UDI-Device Identifier: 06948538365649
• UDI-Public: (01)06948538365649(11)220612
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 07/23/2024

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?: No
• Operator of Device: Lay User/Patient
• Device Model Number: B25A
• Device Catalogue Number: B25A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/10/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/15/2024
• Initial Report FDA Received Date: 07/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/12/2022
• 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