FDA Adverse Event
Injury
Summary report: N
SUNSET CGA 870 STYLE REGULATOR; 0-15 LPM
MDR report key: 25344242
·
Received May 31, 2026
Report
- Report Number
- 3006446479-2026-00002
- Event Type
- Injury
- Date Received
- May 31, 2026
- Date of Event
- March 18, 2026
- Report Date
- May 29, 2026
- Manufacturer
- SINYA - DANYANG XINYA VALVE CO. LTD
- Product Code
- CAN
- UDI-DI
- 00848530060671
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- 501
Narratives
Additional Manufacturer Narrative · 0
N/A
Description of Event or Problem · 0
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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 239513 | SUNSET CGA 870 STYLE REGULATOR; 0-15 LPM | OXYGEN REGULATOR | CAN | SINYA - DANYANG XINYA VALVE CO. LTD | RES043 | 00848530060671 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |