MAUDE Adverse Event Report: JIANGSU JUMAO X-CARE MEDICAL EQUIPMENT CO., LTD COMPASS HEALTH BRANDS; TRUAIRE 5 O2 CONCENTRATOR

Model Number	O2C5L
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/13/2024
Type of Reportable Event	Malfunction
Event or Problem Description
We had a concentrator that caught on fire in a patient's home on (b)(6) 2024.The patient had no injuries and did not require medical attention.The patient was in a different room from the concentrator.The concentrator was located in their bathroom, because they did not like the noise from the concentrator.The daughter used a fire extinguisher to put the out the fire from the concentrator.The fire department was called out by the daughter after the fire was extinguished.Per the daughter, the concentrator was taken by the insurance company.She will ask if she can get it back and let me know.The family called me back and the fire investigator has the concentrator.They just spoke with him, and they will not be releasing the concentrator to anyone.He said they would be happy to do a dual investigation with the manufacturer/company.This event is not considered a mandatory reportable event as there was no report of death or serious injury.The presence or absence of a malfunction cannot be determined with the information currently available.However, the manufacturer has decided to make the fda aware of the incident.

• Brand Name: COMPASS HEALTH BRANDS
• Common Device Name: TRUAIRE 5 O2 CONCENTRATOR
• Manufacturer (Section D): JIANGSU JUMAO X-CARE MEDICAL EQUIPMENT CO., LTD; no.36 danyan road; danyang jiangsu, cn 21230 0; CH 212300
• MDR Report Key: 20256380
• Report Number: 3012316249-2024-00020
• Device Sequence Number: 8013107
• Product Code: CAW
• UDI-Device Identifier: 00092237623152
• UDI-Public: (01)00092237623152(21)
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/19/2024
• Report Date (Section F): 09/19/2024

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: O2C5L
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 08/15/2024
• Device Age: 9 MO
• Date Report to Manufacturer: 09/19/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/19/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown
• Date Report Sent to FDA: 09/19/2024