FDA Adverse Event
Malfunction
Summary report: N
POWERED WHEELCHAIR
MDR report key: 2930929
·
Received January 28, 2013
Report
- Report Number
- 1525712-2013-00651
- Event Type
- Malfunction
- Date Received
- January 28, 2013
- Report Date
- January 26, 2013
- Manufacturer
- INVACARE TAYLOR STREET
- Product Code
- ITI
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OK, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Description of Event or Problem · 1
(B)(4). NO SERIOUS INJURY ALLEGED. MALFUNCTION ALLEGED. PROVIDER STATES NO VOLTAGE TO PINS ONE AND TWO IN THE JOYSTICK. MDR FILED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 37607 | POWERED WHEELCHAIR | 890.3860 | ITI | INVACARE TAYLOR STREET | TDX3 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |