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

Model Number	LG3600
Medical Device Problem Code	Thermal Decomposition of Device (1071)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/09/2023
Type of Reportable Event	Malfunction
Event or Problem Description
React health received a complaint from a durable medical provider stating that a device had evidence of melting where power cord plugs in.The device has been received by react health.The manufacturer has received the device and investigated.
Additional Manufacturer Narrative
The device was returned to bmc for investigation.The power supply was not returned with the unit.The manufacturer confirmed melting at the junction point between the device and the power supply.The device powered on and operated as designed.There was no evidence of internal thermal scorching or burning.The center needle in the power interface was tilted and presumably caused the melting.The manufacturer concludes an improperly seated power cable or non-bmc power supply was the root 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 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: 19592234
• Report Number: 3008566132-2024-00011
• Device Sequence Number: 8470747
• Product Code: BZD
• UDI-Device Identifier: 06948538363331
• UDI-Public: (01)06948538363331(11)221201
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/24/2024

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: 01/23/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/11/2023
• Initial Report FDA Received Date: 06/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/01/2022
• 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