FDA Adverse Event
Malfunction
Summary report: N
POWERED WHEELCHAIR
MDR report key: 3903300
·
Received June 30, 2014
Report
- Report Number
- 1525712-2014-03305
- Event Type
- Malfunction
- Date Received
- June 30, 2014
- Report Date
- May 30, 2014
- Manufacturer
- INVACARE TAYLOR STREET
- Product Code
- ITI
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OR, US
- Reporter Occupation
- PATIENT
Narratives
Description of Event or Problem · 1
CUSTOMER STATES THE CHAIR TURNS ON AND OFF ON ITS OWN. CUSTOMER WAS CALLING TO REQUEST THE RECALL. ADVISED TO CONTACT (B)(6). CUSTOMER STATES THE WIRING IS FRAYED AND BROKEN AS WELL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 380711 | POWERED WHEELCHAIR | 890.3860 | ITI | INVACARE TAYLOR STREET | M51PR |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |