FDA Adverse Event
Other
Summary report: N
COMPANION 41
MDR report key: 842138
·
Received April 25, 2007
Report
- Report Number
- 1825511-2007-00008
- Event Type
- Other
- Date Received
- April 25, 2007
- Date of Event
- December 1, 2006
- Report Date
- March 26, 2007
- Manufacturer
- PURITAN-BENNETT (LOX), CRYOGENIC DIVISION
- Product Code
- BYJ
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KY, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE IS UNAVAILABLE FOR EVALUATION, IT WAS DESTROYED IN THE BLAZE. USER MANUAL WARNS, "DO NOT SMOKE NEAR THIS EQUIPMENT. KEEP CIGARETTES OR BURNING TOBACCO AWAY FROM THE AREA WHERE EQUIPMENT IS OPERATED. INCREASED FIRE RISK. HIGH CONCENTRATIONS OF OXYGEN CAN CAUSE RAPID BURNING OF OTHER SUBSTANCES."
Description of Event or Problem · 1
A PATIENT USING A C41 LIQUID OXYGEN RESERVOIR REMOVED HIS CANNULA TO SMOKE. THE PATIENT PLACED THE CANNULA ON THE FLOOR NEXT TO HIS FEET. THE PATIENT BEGAN SMOKING. THE PATIENT FELL ASLEEP AND THE CIGARETTE FELL INTO HIS LAP AND IGNITED HIS PANTS. A FAMILY MEMBER REMOVED HIS PANTS AND TOSSED THEM TO THE FLOOR. THE PANTS LANDED ON THE CANNULA. THE PATIENT SUFFERED MINOR BURNS. THE HOME WAS A TOTAL LOSS AS A RESULT OF THE FIRE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | COMPANION 41 | STATIONARY LIQUID OXYGEN SYSTEM | BYJ | PURITAN-BENNETT (LOX), CRYOGENIC DIVISION | C41 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |