FDA Adverse Event
Malfunction
Summary report: N
TDXSP ELECTRIC RED EURO WIDE BASE W/ 23-1 SSD GEAR BOX
MDR report key: 4412003
·
Received January 13, 2015
Report
- Report Number
- 1525712-2014-08579
- Event Type
- Malfunction
- Date Received
- January 13, 2015
- Report Date
- November 18, 2014
- Manufacturer
- INVACARE TAYLOR STREET
- Product Code
- ITI
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Description of Event or Problem · 1
DEALER ALLEGES THE TILT ACTUATOR WAS GRINDING AND WENT OUT ON A TDXSR-NCG POWER CHAIR CAUSING THE USER TO BE STRANDED IN THE UP POSITION. DEALER WAS CALLED TO GET THE PATIENT DOWN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 28890 | TDXSP ELECTRIC RED EURO WIDE BASE W/ 23-1 SSD GEAR BOX | WHEELCHAIR, POWERED | ITI | INVACARE TAYLOR STREET | TDXSR-MCG |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |