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

Model Number LG3500

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Inflammation (1932); Unspecified Heart Problem (4454)

Event Date 08/29/2023

Event Type  Injury  

Event Description

A durable medical equipment company contacted react health to report a patient allegation of a luna g3 cpap causing inflammation around their heart.The device was checked by the customer and no problem was found.The device has not yet been returned for evaluation.A follow-up report will be filed once the investigation is complete.

• 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: 18218733
• MDR Text Key: 329143811
• Report Number: 3009096682-2023-00005
• 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
• Report Date: 11/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: LG3500
• Device Catalogue Number: LG3500
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/28/2023
• Distributor Facility Aware Date: 10/30/2023
• Event Location: Home
• Date Report to Manufacturer: 11/28/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/28/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other