FDA Adverse Event
Malfunction
Summary report: N
POWERED WHEELCHAIR
MDR report key: 3071729
·
Received April 22, 2013
Report
- Report Number
- 1525712-2013-03123
- Event Type
- Malfunction
- Date Received
- April 22, 2013
- Report Date
- March 26, 2013
- Manufacturer
- INVACARE TAYLOR STREET
- Product Code
- ITI
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AL, US
- Reporter Occupation
- PATIENT
Narratives
Description of Event or Problem · 1
END USER STATES AFTER HAVING CHAIR SERVICED FROM MED-SOUTH CHAIR HAS A JUMP IN IT WHEN GOING ON SMALL CRACKS CHAIR JOLTS VERY HARD AFTER GOING OVER A THRESHOLD AND HAS THROWN HIM OUT OF THE CHAIR. CONSUMER STATES IT SEEMS TO HAVE SOME TYPE OF LOCK ON IT AND SHUTS DOWN. CUSTOMER HAS HAD SOME BRUISING LEG ALSO HAD SOME PROPERTY DAMAGE DUE TO CHAIR JOLTING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 171934 | POWERED WHEELCHAIR | 890.3860 | ITI | INVACARE TAYLOR STREET | TDXSIV-HD |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 53 | Other |