FDA Adverse Event
Malfunction
Summary report: N
POWERED WHEELCHAIR
MDR report key: 3911843
·
Received July 3, 2014
Report
- Report Number
- 1525712-2014-03425
- Event Type
- Malfunction
- Date Received
- July 3, 2014
- Report Date
- June 2, 2014
- Manufacturer
- UNKNOWN
- Product Code
- ITI
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- LA, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Description of Event or Problem · 1
THE PROVIDER STATES THE CHAIR IS NOISY BUT WAS MISDIAGNOSED BY THE TECHNICIAN. THE PROVIDER STATES A BEARING WAS BAD IN THE CASTER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 391383 | POWERED WHEELCHAIR | 890.3860 | ITI | UNKNOWN | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |