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

Model Number	LG3600
Medical Device Problem Codes	Thermal Decomposition of Device (1071); Device Emits Odor (1425); Sparking (2595)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/12/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned to bmc for investigation and customer complaints were confirmed.The adapter does have a case that melts and drums.Bmc uses a problem-free power adapter and power cord, and the power-on check device can work properly.Bmc has returned the adapter that caught fire to the raw material supplier for investigation and analysis.This fault was caused by the tin slag remaining on the pcb during the production process of the adapter, which caused the internal burning of the adapter, which was an individual device fault.In order to avoid similar problems, the supplier has been asked to strengthen the inspection of welding quality and increase the cleaning action after welding.
Event or Problem Description
React health received a complaint from a durable medical equipment provider stating a patient reported that the power supply on their cpap sparked and created a burning smell.Patient reported that the power brick portion of the power cord was hot and the plastic housing had melted.There is no harm or injury reported.The device has been returned to the importer.The manufacturer has received the device and investigated.

• Brand Name: LUNA G3 APAP
• Common Device Name: VENTILATOR, NON-CONTINUOUS (RESPIRATOR), PRODUCT CODE: BZD
• 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: 20165838
• Report Number: 3008566132-2024-00018
• Device Sequence Number: 17969951
• Product Code: BZD
• UDI-Device Identifier: 06948538363331
• UDI-Public: (01)06948538363331(11)221023
• Combination Product (Y/N): N
• Initial Reporter State: PW
• 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): 09/01/2024

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: LG3600
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/31/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/26/2024
• Initial Report FDA Received Date: 09/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/17/2023
• 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
• Patient Sex: Unknown