FDA Adverse Event
Other
Summary report: N
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
MDR report key: 2120495
·
Received June 3, 2011
Report
- Report Number
- 1525712-2011-00234
- Event Type
- Other
- Date Received
- June 3, 2011
- Report Date
- June 2, 2011
- Manufacturer
- INVACARE
- Product Code
- CAW
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
NO SERIOUS INJURY ALLEGED. CONSUMER STATED HE SMELLED SMOKE. PRODUCT HAS NOT BEEN RETURNED FOR EVALUATION AT THIS TIME SO IT IS UNKNOWN IF A MALFUNCTION OCCURRED OR IF OTHER FACTORS SUCH AS MISUSE, ABUSE, OR LACK OF MAINTENANCE MAY HAVE CAUSED OR CONTRIBUTED TO THIS INCIDENT. MDR FILED AS A CONSERVATIVE MEASURE BASED ON ALLEGATION OF A SMOKE SMELL.
Description of Event or Problem · 1
THE CONSUMER ALLEGES HE SMELLED SMOKE. THERE WAS NO SMOKE VISABLE. NO INJURY IS ALLEGED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL) | 868.5440 | CAW | INVACARE | TPO100B |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 54 YR |