FDA Adverse Event
Malfunction
Summary report: N
POWERED WHEELCHAIR
MDR report key: 3020247
·
Received March 25, 2013
Report
- Report Number
- 1525712-2013-02284
- Event Type
- Malfunction
- Date Received
- March 25, 2013
- Report Date
- February 27, 2013
- Manufacturer
- UNKNOWN
- Product Code
- ITI
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Description of Event or Problem · 1
MDR DECISION DATE: (B)(6). NO SERIOUS INJURY ALLEGED. MALFUNCTION ALLEGED. PER DEALER FUNCTIONS ARE NOT OPERATING CORRECTLY. CHAIR WILL ONLY TURN TO THE RIGHT. MDR FILED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 122627 | POWERED WHEELCHAIR | 890.3860 | ITI | UNKNOWN | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |