FDA Adverse Event
Malfunction
Summary report: N
POWERED WHEELCHAIR
MDR report key: 3020226
·
Received March 25, 2013
Report
- Report Number
- 3004493922-2013-00664
- Event Type
- Malfunction
- Date Received
- March 25, 2013
- Report Date
- February 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
Additional Manufacturer Narrative · 1
(B)(4). THE MALFUNCTION HAS NOT BEEN CONFIRMED.
Description of Event or Problem · 1
DEALER STATED RIGHT GEARBOX IS LEAKING FLUID ONTO THE GROUND.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 122015 | POWERED WHEELCHAIR | 890.3860 | ITI | INVACARE SUZHOU | M51PSEMIRED |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |