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	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/13/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer cannot determine the cause of the event on the basis of information thus far available.The manufacturer continues to request return of the device for further analysis.The manufacturer has conducted independent electrical testing on a device from a proximal lot and month, sn (b)(6) (lot# ja2311, manufacture date: november 24, 2023), and found the device met electrical standards.
Event or Problem Description
A concentrator caught on fire in a patient's bathroom.A definitive root cause could not be determined with the information currently available.The manufacturer continues to request the return of the device for further analysis.It should be noted that the manufacturer has conducted independent electrical testing on a device from a proximal lot and month, (b)(6) (lot# ja2311, manufacture date: november 24, 2023), and determined the device to meet electrical standards.

• 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 21230 0; CH 212300
• Manufacturer Contact: no. 36 danyan road; danyang, jiangsu
• MDR Report Key: 20328761
• Report Number: 3014810929-2024-00002
• Device Sequence Number: 9592132
• 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
• PMA/510(K) Number: K090007
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 09/20/2024

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
• Device Lot Number: JA2312
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/17/2024
• Initial Report FDA Received Date: 09/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/07/2023
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown