FDA Adverse Event
Malfunction
Summary report: N
POWERED WHEELCHAIR
MDR report key: 4213490
·
Received October 30, 2014
Report
- Report Number
- 1525712-2014-07456
- Event Type
- Malfunction
- Date Received
- October 30, 2014
- Date of Event
- October 25, 2014
- Report Date
- October 28, 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
IT WAS REPORTED THAT WHILE THE (B)(4) POWER CHAIR WAS IN DRIVE MODE, WITH MOTOR ENGAGED, THE LEFT BRAKE WAS NOT WORKING PROPERLY, WAS PULLING TO THE RIGHT. THE MOTOR BRAKE LEVER WAS BENT WHICH PREVENTED THE DRIVE MODE TO BE COMPLETELY ENGAGED. DEALER BENT THE BRAKE LEVER BACK AND THE CHAIR IS NOW FUNCTIONING PROPERLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 695510 | POWERED WHEELCHAIR | 890.3860 | ITI | INVACARE TAYLOR STREET | 3GTQ3 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |