FDA Adverse Event
Malfunction
Summary report: N
POWERED WHEELCHAIR
MDR report key: 3103546
·
Received May 9, 2013
Report
- Report Number
- 1525712-2013-03681
- Event Type
- Malfunction
- Date Received
- May 9, 2013
- Report Date
- April 15, 2013
- Manufacturer
- INVACARE TAYLOR STREET
- Product Code
- ITI
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Description of Event or Problem · 1
DEALER STATES THE MOTOR IS CLICKING AND NOISY. DEALER STATES THE DEVICE HAS A BURNT SMELL TO IT. DEALER WAS NOT ABLE TO EXACTLY IDENTIFY WHERE THE SMELL IS COMING FROM AT THIS TIME. QUOTE (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 203009 | POWERED WHEELCHAIR | 890.3860 | ITI | INVACARE TAYLOR STREET | M51-CG |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |