FDA Adverse Event
Other
Summary report: N
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
MDR report key: 2013059
·
Received March 1, 2011
Report
- Report Number
- 1525712-2011-00072
- Event Type
- Other
- Date Received
- March 1, 2011
- Date of Event
- February 1, 2011
- Report Date
- March 1, 2011
- Manufacturer
- INVACARE
- Product Code
- CAW
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UT, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEALER CONTACTED MANUFACTURER THAT THE CONSUMER STATES, THE UNIT HAS A BURNING SMELL. UNIT IS OVER TWO YEARS OLD AND DEVICE SERVICE AND MAINTENANCE HISTORY ARE UNKNOWN. IT IS UNKNOWN IF DEVICE WAS DROPPED AND DAMAGED PRIOR TO ALLEGED INCIDENT. MDR FILED SOLELY ON COMPLAINT THAT DEVICE HAS AN ALLEGED BURNING SMELL. MALFUNCTION IS NOT CONFIRMED. MANUFACTURER IS ATTEMPTING TO OBTAIN PRODUCT FOR INSPECTION.
Description of Event or Problem · 1
THE DEALER STATES, THE CONSUMER ALLEGES THE UNIT HAS A BURNING SMELL. 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 | IRC5P |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |