FDA Adverse Event
Other
Summary report: N
FNL LIBERATOR 45 TF G3 SPAIN
MDR report key: 1368837
·
Received April 23, 2009
Report
- Report Number
- 3004822415-2009-00001
- Event Type
- Other
- Date Received
- April 23, 2009
- Date of Event
- October 16, 2007
- Report Date
- April 10, 2009
- Manufacturer
- CAIRE, INC.
- Product Code
- BYJ
- PMA / PMN Number
- K800742
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SP
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
ACCIDENT IN USING OF A LOX RESPIRATORY THERAPY DURING THE LIGHTING OF A GAS HEATER BECAUSE OF DEFLAGRATION AND OXYGEN MASK COMBUSTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FNL LIBERATOR 45 TF G3 SPAIN | LOX BASE UNIT | BYJ | CAIRE, INC. | LIBERATOR 45 TF |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 74 YR | Other |