FDA Adverse Event
Malfunction
Summary report: N
POWERED WHEELCHAIR
MDR report key: 4211185
·
Received October 29, 2014
Report
- Report Number
- 3008262382-2014-01757
- Event Type
- Malfunction
- Date Received
- October 29, 2014
- Report Date
- October 8, 2014
- Manufacturer
- INVACARE REHABILITATION EQUIP
- Product Code
- ITI
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Description of Event or Problem · 1
HEATHER AT WSR HEARD FROM HER TECH WHO SPOKE TO THE END USER THAT THE JOYSTICK THAT WAS REPLACED UNDER RECALL IS HAVING PROBLEMS. WHEN THE JOYSTICK IS SET FOR SLOW-SPEED HE HAS TO MOVE THE INDUCTIVE 3 TO 5 TIMES TO GET IT TO MOVE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 691937 | POWERED WHEELCHAIR | 890.3860 | ITI | INVACARE REHABILITATION EQUIP | M41SR16R |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |