FDA Adverse Event
Malfunction
Summary report: N
TDXSP ELECTRIC RED EURO WIDE BASE W/ 23-1 SSD GEAR BOX
MDR report key: 5049969
·
Received September 2, 2015
Report
- Report Number
- 1525712-2015-04446
- Event Type
- Malfunction
- Date Received
- September 2, 2015
- Report Date
- August 7, 2015
- Manufacturer
- INVACARE TAYLOR STREET
- Product Code
- ITI
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL RECORD WILL BE FILED.
Description of Event or Problem · 1
PROVIDER STATES THE END USER ALLEGES THE JOYSTICK WAS SMOKING AND THE END OF THE JOYSTICK CABLE CONNECTION WAS MELTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 583250 | TDXSP ELECTRIC RED EURO WIDE BASE W/ 23-1 SSD GEAR BOX | WHEELCHAIR, POWERED | ITI | INVACARE TAYLOR STREET | TDXSIV-HD |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |