FDA Adverse Event
Malfunction
Summary report: N
POWERED WHEELCHAIR
MDR report key: 3133251
·
Received May 29, 2013
Report
- Report Number
- 1525712-2013-04204
- Event Type
- Malfunction
- Date Received
- May 29, 2013
- Date of Event
- May 1, 2013
- Report Date
- May 2, 2013
- Manufacturer
- INVACARE TAYLOR STREET
- Product Code
- ITI
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Description of Event or Problem · 1
THE DEALER REPORTS THAT WHEN THE J/S IS TURNED ON THE ACTUATOR WILL CONTINUOUSLY RUN UNTIL IT IS DISCONNECTED OR THE CHAIR IS SHUT DOWN. (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 235357 | POWERED WHEELCHAIR | 890.3860 | ITI | INVACARE TAYLOR STREET | TDXSP-CG |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |