FDA Adverse Event
Other
Summary report: N
POWERED WHEELCHAIR
MDR report key: 2100395
·
Received May 16, 2011
Report
- Report Number
- 1525712-2011-00202
- Event Type
- Other
- Date Received
- May 16, 2011
- Date of Event
- April 15, 2011
- Report Date
- May 13, 2011
- Manufacturer
- INVACARE
- Product Code
- ITI
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEALER CONTACTED THE MFR STATING THE CONSUMER'S CHAIR HAD SMOKE COMING FROM THE MOTOR. NO INJURY WAS REPORTED. ASSUMING MALFUNCTION WITHIN THE MOTOR, NO RISK OF FIRE IS PRESENT. THE MOTOR IS ENCASED WITHIN A METAL HOUSING. MDR FILED BASED ON ALLEGATION OF SMOKE.
Description of Event or Problem · 1
THE CONSUMER WAS SITTING IN THE CHAIR WHEN THE MOTOR ALLEGEDLY STARTED TO SMOKE AND WAS HOT. NO INJURY IS ALLEGED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | POWERED WHEELCHAIR | 890.3860 | ITI | INVACARE | TDXSP |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |