FDA Adverse Event
Malfunction
Summary report: N
POWERED WHEELCHAIR
MDR report key: 4113654
·
Received September 24, 2014
Report
- Report Number
- 1525712-2014-06258
- Event Type
- Malfunction
- Date Received
- September 24, 2014
- Report Date
- September 3, 2014
- Manufacturer
- INVACARE TAYLOR STREET
- Product Code
- ITI
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- LA, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Description of Event or Problem · 1
IT WAS REPORTED BY THE PROVIDER THAT THE CONTROLLER IS FAULTY, INTERMITTENT STOPPING AND GOING. THERE WERE NO REPORTS OF PATIENT INJURY OR PROPERTY DAMAGE, NO ADDITIONAL INFORMATION PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 595339 | POWERED WHEELCHAIR | 890.3860 | ITI | INVACARE TAYLOR STREET | R2MWD-PS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |