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

Model Number	O2C5L
Medical Device Problem Code	Fire (1245)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/17/2024
Type of Reportable Event	Malfunction
Event or Problem Description
O2 concentrator caught on fire.They put the fire out and there were no injuries.Property management for the company stated unit caught fire in a resident's room in our skilled nursing care.The control area of the device is where the fire started.

• Brand Name: ROSCOE MEDICAL TRUAIRE
• Common Device Name: O2 CONCENTRATOR
• Manufacturer (Section D): JIANGSU JUMAO X-CARE MEDICAL EQUIPMENT CO., LTD; no.36 danyan road; danyang, jiangsu 21230 0; CH 212300
• MDR Report Key: 20694910
• Report Number: 3012316249-2024-00022
• Device Sequence Number: 12401112
• Product Code: CAW
• UDI-Device Identifier: 00092237623152
• UDI-Public: 00092237623152
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 11/15/2024
• Report Date (Section F): 11/15/2024

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: Health Professional
• Device Model Number: O2C5L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/24/2024
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 10/18/2024
• Device Age: 10 MO
• Event Location: Nursing Home
• Date Report to Manufacturer: 11/15/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/15/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 11/15/2024