MAUDE Adverse Event Report: JIANGSU JUMAO X-CARE MEDICAL, DANYANG, JIANGSU PRC DIRECT SUPPLY ATTENDANT 5L OXYGEN CONCENTRATOR; GENERATOR, OXYGEN, PORTABLE

Model Number	A5LC-1
Medical Device Problem Code	Arcing (2583)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/15/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Unit was smoking.Caught on fire.Put out with a fire hose.Put in the parking lot.At (b)(6) 2025 at 11:10am, called to report an incident that allegedly involved the following product or device: oxygen concentrator.Reported that the following occurred at (b)(6) 2025 at 9:05am: allegedly the power switch was turned on and inside fire started.Unit was smoking and they put it out with water hose and have put it outside in the parking lot away from the building.There were no injuries according to reporter.The product has been taken out of use.
Additional Manufacturer Narrative
Melting of the housing occurred and was limited to adjacent to the hour counter.

• Brand Name: DIRECT SUPPLY ATTENDANT 5L OXYGEN CONCENTRATOR
• Common Device Name: GENERATOR, OXYGEN, PORTABLE
• Manufacturer (Section D): JIANGSU JUMAO X-CARE MEDICAL, DANYANG, JIANGSU PRC; no. 36 danyan road; danyang, jiangsu 21230 0; CH 212300
• Manufacturer (Section G): JIANGSU JUMAO X-CARE MEDICAL, DANYANG, JIANGSU PRC; no. 36 danyan road; danyang, jiangsu 21230 0; CH 212300
• Manufacturer Contact: no. 36 danyan road; danyang, jiangsu 21230-0
• MDR Report Key: 23046007
• Report Number: 3014810929-2025-00018
• Device Sequence Number: 9663219
• Product Code: CAW
• UDI-Device Identifier: 06972855530022
• UDI-Public: (01)06972855530022(11)231205(10)231201A
• Combination Product (Y/N): N
• 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: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 09/10/2025

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
• Device Model Number: A5LC-1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/03/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/05/2023
• Usage of Device: Unknown
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-0795-2025
• Patient Sequence Number: 1
• Patient Sex: Unknown