FDA Adverse Event
Malfunction
Summary report: N
POWERED WHEELCHAIR
MDR report key: 3180991
·
Received June 20, 2013
Report
- Report Number
- 1525712-2013-04872
- Event Type
- Malfunction
- Date Received
- June 20, 2013
- Date of Event
- May 10, 2013
- Report Date
- June 19, 2013
- Manufacturer
- INVACARE TAYLOR STREET
- Product Code
- ITI
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- DE, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
(B)(4). PER RESPONSE FROM PROVIDER (RECEIVED ON (B)(4) 2013) THE END USER'S POWERCHAIR WAS GOING INTO CIRCLES. NO INJURY OR MEDICAL INTERVENTION REPORTED.
Description of Event or Problem · 1
PER PROVIDER THE END USER'S, WHILE AT THE DAYCARE, POWERCHAIR WAS GOING INTO CIRCLES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 280744 | POWERED WHEELCHAIR | 890.3860 | ITI | INVACARE TAYLOR STREET | TDXSP-CG |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |