MAUDE Adverse Event Report: SINYA - DANYANG XINYA VALVE CO. LTD SUNSET CGA 870 STYLE REGULATOR; 0-15 LPM; OXYGEN REGULATOR

Model Number	RES043
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Partial thickness (Second Degree) Burn (2694); Full thickness (Third Degree) Burn (2696)
Date of Event	03/18/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
N/a.
Event or Problem Description
Sunset healthcare solutions received an fda medwatch report that a vitas healthcare patient was smoking in the presence of her portable oxygen tank when it caught fire.It was stated that the oxygen tank was on and caught fire, resulting in 2nd and 3rd degree burns to her face, hands, and shoulders.She was transported by helicopter to a burn unit for medical attention.

• Brand Name: SUNSET CGA 870 STYLE REGULATOR; 0-15 LPM
• Common Device Name: OXYGEN REGULATOR
• Manufacturer (Section D): SINYA - DANYANG XINYA VALVE CO. LTD; no. 12 dongjin west road; yanling town; danyang, 21234 1; CH 212341
• Manufacturer Contact: maggie hsu ; no. 12 dongjin west road; yanling town; danyang, 21234-1 ; CH 212341
• MDR Report Key: 25344242
• Report Number: 3006446479-2026-00002
• Device Sequence Number: 5105497
• Product Code: CAN
• UDI-Device Identifier: 00848530060671
• UDI-Public: (01)00848530060671
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 05/29/2026

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?: No
• Operator of Device: Lay User/Patient
• Device Model Number: RES043
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Concomitant Medical Products and Therapy/Usage Dates: COMMODE BEDSIDE; CONCENTRATOR 10L; O2 RACK - E CYLINDER (6 BAY); REGULATOR; WHEELCHAIR COMPANION 18"; WHEELCHAIR FOOT RESTS (PAIR)
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening
• Patient Age: 64 YR
• Patient Sex: Female
• Patient Weight: 50 KG
• Patient Race: White