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

Model Number	B25A
Medical Device Problem Code	Temperature Problem (3022)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/10/2023
Type of Reportable Event	Malfunction
Event or Problem Description
React health received a complaint from a durable medical provider stating that a patient claimed that their device's humidifier was getting hot enough to boil water and melt plastic.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, customer complaints were confirmed, and there were no allegations of serious or permanent injury or injury.There is no allegation of serious or permanent harm or injury patient.Through the disassembly inspection and test, it is found that the over-temperature problem is caused by the r164 sampling resistance virtual welding on the motherboard.The shell of the equipment is intact and the measured shell temperature meets the standard requirements, and no melt plastic is found.The product in the design, taking into account the normal operation of the device and a single failure, in accordance with the standard requirements for development and design.Under the single fault of r164 sampling resistance virtual welding, the test results meet the expected design output and meet the standard requirements.This fault is an individual device fault and will not affect personal safety and effectiveness.In consideration of the danger that the user may touch the heating plate unexpectedly, the manufacturer labels the heating plate with the warning "hot surface".

• 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: 19805988
• Report Number: 3008566132-2024-00010
• Device Sequence Number: 8389600
• Product Code: BZD
• UDI-Device Identifier: 06948538365601
• UDI-Public: (01)06948538365601(11)220328
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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): 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?: Yes
• 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: 01/23/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/11/2023
• Initial Report FDA Received Date: 07/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/28/2022
• 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