FDA Adverse Event
Malfunction
Summary report: N
POWERED WHEELCHAIR
MDR report key: 3883873
·
Received June 19, 2014
Report
- Report Number
- 3008262382-2014-00118
- Event Type
- Malfunction
- Date Received
- June 19, 2014
- Report Date
- May 21, 2014
- Manufacturer
- INVACARE REHABILITATION EQUIP
- 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
DEALER ALLEGED THE SCREW ON THE SEAT POST LOOSENED AND HOLLOWED OUT THE HOLE CAUSING THE SCREW TO NO LONGER BE ABLE TO BE TIGHTENED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 361580 | POWERED WHEELCHAIR | 890.3860 | ITI | INVACARE REHABILITATION EQUIP | M41SRB |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |