FDA Adverse Event
Malfunction
Summary report: N
POWERED WHEELCHAIR
MDR report key: 3625955
·
Received February 13, 2014
Report
- Report Number
- 3004493922-2014-00206
- Event Type
- Malfunction
- Date Received
- February 13, 2014
- Report Date
- January 27, 2014
- Manufacturer
- INVACARE SUZHOU
- 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
IT WAS REPORTED THE POWERED WHEELCHAIR INAPPROPRIATELY ALLOWS THE END USER TO DRIVE WHILE ATTACHED TO THE CHARGER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 95317 | POWERED WHEELCHAIR | 890.3860 | ITI | INVACARE SUZHOU | M51PSR20R |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |