FDA Adverse Event
Other
Summary report: N
POWERED WHEELCHAIR
MDR report key: 2030179
·
Received March 15, 2011
Report
- Report Number
- 1525712-2011-00091
- Event Type
- Other
- Date Received
- March 15, 2011
- Date of Event
- February 23, 2009
- Report Date
- March 11, 2011
- Manufacturer
- INVACARE
- Product Code
- ITI
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEALER STATED THE CONSUMER SMELLED SMOKE. THE CHAIR HAD BEEN IN SERVICE FOR NEARLY 8 YEARS AND IS NO LONGER IN WARRANTY. INFO SUGGESTS THE AC LINE CORD WAS DAMAGED. MALFUNCTION HAS NOT BEEN ESTABLISHED. THE AC LINE CORD HAS NOT BEEN RETURNED TO INVACARE SO IT IS UNK IF FACTORS OF MISUSE, ABUSE OR LACK OF MAINTENANCE CAUSED OR CONTRIBUTED TO THIS EVENT. OPERATOR'S GUIDE HAS INSTRUCTIONS FOR SAFE AND PROPER USE OF THE PRODUCT, INCLUDING MAINTENANCE. THE CHARGER WAS REPLACED AND THE CHAIR REMAINS IN SERVICE.
Description of Event or Problem · 1
THE CHAIR ALLEGEDLY STARTED TO CRACKLE AND POP WHILE CHARGING. THE CONSUMER ALLEGED SMELLED SMOKE. NO INJURY IS ALLEGED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | POWERED WHEELCHAIR | 890.3860 | ITI | INVACARE | M91 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |