FDA Adverse Event
Malfunction
Summary report: N
POWERED WHEELCHAIR
MDR report key: 3230594
·
Received July 16, 2013
Report
- Report Number
- 3004493922-2013-01513
- Event Type
- Malfunction
- Date Received
- July 16, 2013
- Report Date
- June 26, 2013
- Manufacturer
- INVACARE SUZHOU
- Product Code
- ITI
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT THE MOTOR GEARBOX OF A M51 POWER WHEELCHAIR WAS LEAKING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 328061 | POWERED WHEELCHAIR | 890.3860 | ITI | INVACARE SUZHOU | M51PSR20B |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |