FDA Adverse Event
Malfunction
Summary report: N
POWERED WHEELCHAIR
MDR report key: 3790686
·
Received May 5, 2014
Report
- Report Number
- 1525712-2014-02301
- Event Type
- Malfunction
- Date Received
- May 5, 2014
- Report Date
- March 29, 2014
- Manufacturer
- INVACARE TAYLOR STREET
- Product Code
- ITI
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- PATIENT
Narratives
Description of Event or Problem · 1
END USERS STATED THAT THEIR BACK UP CHAIR, A TDX5-PS POWER CHAIR, WILL ROLL BACKWARDS WHEN ON AND INCLINE WITH THE BRAKES ENGAGED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 269451 | POWERED WHEELCHAIR | 890.3860 | ITI | INVACARE TAYLOR STREET | TDX5-PS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |