FDA Adverse Event
Malfunction
Summary report: N
POWERED WHEELCHAIR
MDR report key: 3699625
·
Received March 25, 2014
Report
- Report Number
- 3004493922-2014-00359
- Event Type
- Malfunction
- Date Received
- March 25, 2014
- Report Date
- February 24, 2014
- Manufacturer
- INVACARE SUZHOU
- Product Code
- IOR
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE BOLT THAT ATTACHES THE SEAT TO THE SEAT POST ON THE POWER WHEELCHAIR IS LOOSE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 174640 | POWERED WHEELCHAIR | 890.3860 | IOR | INVACARE SUZHOU | M41SRB |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |