FDA Adverse Event
Malfunction
Summary report: N
POWERED WHEELCHAIR
MDR report key: 2884512
·
Received December 22, 2012
Report
- Report Number
- 1525712-2012-03234
- Event Type
- Malfunction
- Date Received
- December 22, 2012
- Date of Event
- November 24, 2012
- Report Date
- December 21, 2012
- Manufacturer
- UNKNOWN
- Product Code
- ITI
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Description of Event or Problem · 1
(B)(6) -2012 - THE DEALER REPORTED THAT THE UNKNOWN MODEL AND SERIAL NUMBERS POWER WHEELCHAIR WAS UNABLE TO REVERSE, AND THE JOYSTICK HAS FELL OFF. THERE WAS NO PATIENT INJURY REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | POWERED WHEELCHAIR | 890.3860 | ITI | UNKNOWN | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 37 | Other |