MAUDE Adverse Event Report: JIANGSU JUMAO X-CARE MEDICAL EQUIPMENT CO., LTD. DIRECT SUPPLY ATTENDANT 5L OXYGEN CONCENTRATOR; GENERATOR, OXYGEN, PORTABLE

Model Number	A5LC-1
Medical Device Problem Code	Arcing (2583)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/28/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6), 2025 this facility had a malfunction in a leased oxygen concentrator, manufactured by direct supply manufacturing inc., attendant 5l oxygen concentrator, model: a5lc-1, the concentrator began to produce smoke, filling room n112 and corridor with smoke setting off the fire alarm.The staff removed the concentrator from the building to the rear service parking lot.At that time it started producing flames and the staff extinguished the machine with a fire extinguisher.2 residents and 8 staff were transported to the hospital out of precaution and released.

• Brand Name: DIRECT SUPPLY ATTENDANT 5L OXYGEN CONCENTRATOR
• Common Device Name: GENERATOR, OXYGEN, PORTABLE
• Manufacturer (Section D): JIANGSU JUMAO X-CARE MEDICAL EQUIPMENT CO., LTD.; no.36 danyan road; danyang, jiangsu 21230 0; CH 212300
• Manufacturer (Section G): 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 21230-0
• MDR Report Key: 23590460
• Report Number: 3014810929-2025-00022
• Device Sequence Number: 10159964
• Product Code: CAW
• UDI-Device Identifier: 06972855530022
• UDI-Public: (01)06972855530022(11)231206(10)231202A
• Combination Product (Y/N): N
• Initial Reporter State: WV
• 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
• Type of Report: Initial
• Report Date (Section B): 11/18/2025

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?: Yes
• Device Model Number: A5LC-1
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/06/2023
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown