FDA Adverse Event
Malfunction
Summary report: N
POWERED WHEELCHAIR
MDR report key: 2192401
·
Received August 5, 2011
Report
- Report Number
- 1525712-2011-00422
- Event Type
- Malfunction
- Date Received
- August 5, 2011
- Date of Event
- July 14, 2011
- Report Date
- August 4, 2011
- Manufacturer
- INVACARE
- Product Code
- ITI
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE IS NOT WATERPROOF AND IS NOT LABELED AS SUCH. CONTROLLER ELECTRONICS ARE ENCLOSED IS IN A METAL CASE WHICH DOES OFFER SOME PROTECTION AGAINST FLUID INGRESS. ELECTRONIC MALFUNCTIONS WITHIN THE CONTROLLER, INCLUDING ANY DEBRIS THAT MAY RESULT, ARE WELL CONTAINED WITHIN THE METAL ENCLOSURE OF THE DEVICE. AS IN MANY ELECTRONIC COMPONENT FAILURES, SOME DEGREE OF SMOKING LIKELY OCCURRED HOWEVER THIS IS NOT AN INDICATION OF SUSTAINED COMBUSTION. MALFUNCTION HAS NOT BEEN ESTABLISHED. IF DEVICE IS RETURNED AND THE EVALUATION SUGGESTS A DIFFERING CONCLUSION THIS DECISION WILL BE REVIEWED.
Description of Event or Problem · 1
THE ELEVATING ACTUATOR ALLEGEDLY HAS A BURNING SMELL. THE MOTOR IS BEING REPLACED UNDER WARRANTY. NO INJURY IS ALLEGED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | POWERED WHEELCHAIR | 890.3860 | ITI | INVACARE | TDXSP-MCG |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |