FDA Adverse Event
Death
Summary report: N
AIRSEP
MDR report key: 1064614
·
Received June 17, 2008
Report
- Report Number
- 1064614
- Event Type
- Death
- Date Received
- June 17, 2008
- Date of Event
- June 2, 2008
- Report Date
- June 12, 2008
- Manufacturer
- AIR SEP CORP
- Product Code
- CAW
- Adverse Event
- Yes
- Report Source
- User Facility report
- Reporter Location
- NJ, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
WHILE ON AN O2 GENERATING MACHINE, THE VICTIM DIED FROM INHALING THE PRODUCTS OF COMBUSTION. IT IS BELIEVED THAT THE O2 MACHINE CAUGHT FIRE, AND PUMPED SMOKE INTO THE NASAL CANNULA THAT THE VICTIM WAS USING. VICTIM WAS ALSO A SMOKER, AND WAS PROBABLY SMOKING AT TIME OF FIRE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | AIRSEP | AIR JEN NEW LIFE ELITE | CAW | AIR SEP CORP | NEW LIFE ELITE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR | Death |