MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-09-16 for CHAMPION SERIES 54 manufactured by Champion.
[2199225]
Champion hemodialysis chair model 54 series, serial number (b)(4), foot mechanism has sharp metal edges. Pt's leg was resting off footrest and pt's leg was found to be cut and bleeding against sharp metal edge. This incident resulted in small skin tear. Rn placed dressing over the wound. Biomedical technologist notified this model of champion hemodialysis chair does not have padding or cover over foot mechanism. Older champion chairs have plastic or padding over mechanism. Newest chairs have plastic or padding over metal foot mechanism.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5022297 |
| MDR Report Key | 2261364 |
| Date Received | 2011-09-16 |
| Date of Report | 2011-09-16 |
| Date of Event | 2011-09-05 |
| Date Added to Maude | 2011-09-26 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CHAMPION |
| Generic Name | HEMODIALYSIS CHAIR |
| Product Code | FIA |
| Date Received | 2011-09-16 |
| Model Number | SERIES 54 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CHAMPION |
| Manufacturer Address | ELKHART IN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2011-09-16 |