FDA Adverse Event
Summary report: N
POWERED WHEELCHAIR
MDR report key: 2940339
·
Received February 2, 2013
Report
- Report Number
- 1525712-2013-00798
- Date Received
- February 2, 2013
- Report Date
- February 2, 2013
- Manufacturer
- INVACARE TAYLOR STREET
- Product Code
- ITI
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OK, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Description of Event or Problem · 1
(B)(6) -THE DEALER REPORTED THAT THE M91 POWER WHEELCHAIR JOYSTICK WAS LOGGING ON AND INCREASING SPEED WITHOUT COMMAND. DURING ONE OF THESE EPISODES IT RAN INTO THE TV STAND, THE TV FELL OFF, HITTING PATIENT'S RIGHT KNEE, AND LANDING ON HIS LEFT FOOT. EMERGENCY MEDICAL ATTENTION WAS SOUGHT AS PATIENT SUSTAINED CUTS AND BROKEN BONES ON HIS LEFT FOOT. SHOULD WE RECEIVE ADDITIONAL INFORMATION, THIS FILE WILL BE REVIEWED, AND A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 45524 | POWERED WHEELCHAIR | 890.3860 | ITI | INVACARE TAYLOR STREET | M91 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 78 | Other |