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

Model Number LG3500

Device Problems Leak/Splash (1354); Unexpected Shutdown (4019)

Patient Problem Dyspnea (1816)

Event Date 11/14/2023

Event Type  malfunction  

Event Description

React health received a complaint from a durable medical equipment provider stating that the machine is blowing water straight out and causing a choking hazard to the patient.The equipment provider also stated the device was stopping during the night and the patient could not catch their breathe.No patient harm or injury has been reported.The device has been received by the importer and the evaluation is pending.Once the investigation is complete a follow up report will be submitted.

Manufacturer Narrative

This report was previously submitted to the fda as an importer.This was incorrect.This complaint did not contain an allegation of patient death or serious harm or injury but a possible malfunction only.Per title 21, part 803 this report should only be forwarded to the manufacturer.

• Brand Name: LUNA G3 CPAP
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): BMC MEDICAL CO., LTD; room 110 tower a fengyu bldg; no.115 fucheng road; haidian, beijing 10003 6; CH 100036
• MDR Report Key: 18318054
• MDR Text Key: 330377734
• Report Number: 3009096682-2023-00011
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 01/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: LG3500
• Device Catalogue Number: LG3500
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/18/2024
• Distributor Facility Aware Date: 11/14/2023
• Device Age: 2 YR
• Event Location: Home
• Date Report to Manufacturer: 01/18/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1