FDA Adverse Event
Malfunction
Summary report: N
POWERED WHEELCHAIR
MDR report key: 3090814
·
Received May 2, 2013
Report
- Report Number
- 1525712-2013-03482
- Event Type
- Malfunction
- Date Received
- May 2, 2013
- Date of Event
- April 5, 2013
- Report Date
- April 8, 2013
- Manufacturer
- INVACARE TAYLOR STREET
- Product Code
- ITI
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Description of Event or Problem · 1
DEALER AND TECH STATE THAT THE GEARBOX SEAL IS BROKEN AND THE GEARBOX LEAKED OIL ALL OVER THE CARPET AND NOW IT WON'T WORK.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 192329 | POWERED WHEELCHAIR | 890.3860 | ITI | INVACARE TAYLOR STREET | TDXSP-CG |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 | Other |