FDA Adverse Event
Malfunction
Summary report: N
POWER CHAIR 20 WIDE BY 18 DEEP FOR PMI
MDR report key: 4556290
·
Received March 2, 2015
Report
- Report Number
- 1525712-2015-01497
- Event Type
- Malfunction
- Date Received
- March 2, 2015
- Report Date
- February 20, 2015
- Manufacturer
- INVACARE TAYLOR STREET
- Product Code
- ITI
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- LA, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Description of Event or Problem · 1
PROVIDER STATES THIS IS THE 3RD SET OF ENGAGEMENT KNOBS THAT THE 3 SEATED PINS HAVE SOMEHOW WORKED THEMSELVES OUT OF. WE ARE REPLACING A COMPLETE WHEEL ASSEMBLY ON BOTH SIDES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 144457 | POWER CHAIR 20 WIDE BY 18 DEEP FOR PMI | WHEELCHAIR, POWERED | ITI | INVACARE TAYLOR STREET | 3GTQ-CG |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |