FDA Adverse Event
Malfunction
Summary report: N
POWERED WHEELCHAIR
MDR report key: 3910079
·
Received July 2, 2014
Report
- Report Number
- 1525712-2014-03385
- Event Type
- Malfunction
- Date Received
- July 2, 2014
- Date of Event
- May 22, 2014
- Report Date
- May 29, 2014
- Manufacturer
- INVACARE TAYLOR STREET
- Product Code
- ITI
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Description of Event or Problem · 1
PER PROVIDER LEFT MOTOR BRAKE LEVER HAS TOO MUCH PLAY, RESULTING IN A 0600 ERROR CODE, NO INJURIES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 386379 | POWERED WHEELCHAIR | 890.3860 | ITI | INVACARE TAYLOR STREET | TDXSP-CG |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |