FDA Adverse Event
Malfunction
Summary report: N
POWERED WHEELCHAIR
MDR report key: 3081514
·
Received April 29, 2013
Report
- Report Number
- 1525712-2013-03305
- Event Type
- Malfunction
- Date Received
- April 29, 2013
- Report Date
- April 1, 2013
- Manufacturer
- INVACARE TAYLOR STREET
- Product Code
- ITI
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Description of Event or Problem · 1
(B)(4). NO SERIOUS INJURY ALLEGED. MALFUNCTION ALLEGED.DEALER STATES THE TILT MAKES A NOISE WHEN LIFTING UP. DEALER SAYS THE USER SAYS THE TILT WOULD DROP DOWN A LITTLE WHEN TILTING. MDR FILED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 183910 | POWERED WHEELCHAIR | 890.3860 | ITI | INVACARE TAYLOR STREET | TDXSP |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |