FDA Adverse Event
Malfunction
Summary report: N
POWERED WHEELCHAIR
MDR report key: 2940289
·
Received February 2, 2013
Report
- Report Number
- 3004493922-2013-00223
- Event Type
- Malfunction
- Date Received
- February 2, 2013
- Report Date
- January 4, 2013
- Manufacturer
- INVACARE SUZHOU
- Product Code
- ITI
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
(B)(4) HAS BEEN INITIATED FOR THIS ISSUE. THE MALFUNCTION HAS NOT BEEN CONFIRMED.
Description of Event or Problem · 1
PROVIDER STATES LEFT MOTOR FAULT. DEALER WANTS REPLACEMENT BASE UNDER POWER CHAIR PROMISE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 45452 | POWERED WHEELCHAIR | 890.3860 | ITI | INVACARE SUZHOU | M41RB |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |