FDA Adverse Event
Malfunction
Summary report: N
POWERED WHEELCHAIR
MDR report key: 3073567
·
Received April 23, 2013
Report
- Report Number
- 1525712-2013-03187
- Event Type
- Malfunction
- Date Received
- April 23, 2013
- Report Date
- March 28, 2013
- Manufacturer
- INVACARE TAYLOR STREET
- Product Code
- ITI
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Description of Event or Problem · 1
POTENTIAL FOR INJURY ASSOCIATED WITH AN FDX CUSTOM POWER WHEELCHAIR WHERE THE BOLT IS BROKEN AT THE END OF THE MOTOR. THIS EVENT COULD RESULT IN INCONSISTENT OPERATION OF THE UNIT WHICH COULD RESULT IN INJURY TO THE USER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 175388 | POWERED WHEELCHAIR | 890.3860 | ITI | INVACARE TAYLOR STREET | FDX |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |