FDA Adverse Event
Malfunction
Summary report: N
POWERED WHEELCHAIR
MDR report key: 3230095
·
Received July 16, 2013
Report
- Report Number
- 1525712-2013-05798
- Event Type
- Malfunction
- Date Received
- July 16, 2013
- Date of Event
- June 22, 2013
- Report Date
- June 25, 2013
- Manufacturer
- INVACARE TAYLOR STREET
- Product Code
- ITI
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Description of Event or Problem · 1
THE DEALER STATES THE CHIR HAS TIPPED OVER SEVERAL TIMES. HE STATES DOWN HILL ONCE, ((B)(4)) AND ONCE OVER A CURB ((B)(4)). THE DEALER THINKS IT'S THE DRIVERS ERROR. THE DEALER STATES NO ABNORMAL DAMAGE, BUT THE CUSTOMER IS NOT THE BEST DRIVER AND HAS DAMAGED ARM PADS FROM TIPPING OVER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 328486 | POWERED WHEELCHAIR | 890.3860 | ITI | INVACARE TAYLOR STREET | M91 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |