FDA Adverse Event
Malfunction
Summary report: N
POWERED WHEELCHAIR
MDR report key: 3123023
·
Received May 21, 2013
Report
- Report Number
- 3004493922-2013-01097
- Event Type
- Malfunction
- Date Received
- May 21, 2013
- Report Date
- April 26, 2013
- 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
PROVIDER STATED THE CHAIR IS SURGING AND VERY SLOW SPEED WHEN THE SPEED IS TURNED UP, QUOTE # (B)(4) ISSUED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 223616 | POWERED WHEELCHAIR | 890.3860 | ITI | INVACARE SUZHOU | M51PSEMIBLUE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |