MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2015-04-28 for RHEO KNEE 3 RKN130007 manufactured by Ossur.
[5703300]
The above knee amputee patient experienced warning signals in the form of buzzing and flashing red light from the prosthetic knee and was not able to charge the knee. She knew it was not working but chose to walk on it anyway. One night she used her prosthesis to walk to the bathroom and fell while she was in the bathroom. She was not injured but she did need to call the fire department to help her back up because the space was too confined for her to get up on her own.
Patient Sequence No: 1, Text Type: D, B5
[13259134]
The event is considered to be a result of the user operating the unit while being aware that it was not turned on. In case of this event the user can use a manual lock to lock the unit in stance.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3003764610-2015-00009 |
| MDR Report Key | 4743278 |
| Report Source | 05 |
| Date Received | 2015-04-28 |
| Date of Report | 2015-04-28 |
| Date of Event | 2015-03-01 |
| Date Mfgr Received | 2015-03-13 |
| Date Added to Maude | 2015-06-09 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | KAREN MONTES |
| Manufacturer Street | 27051 TOWNE CENTRE |
| Manufacturer City | FOOTHILL RANCH CA 92610 |
| Manufacturer Country | US |
| Manufacturer Postal | 92610 |
| Manufacturer Phone | 9493823741 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RHEO KNEE 3 |
| Generic Name | ASSEMBLY, KNEE/SHANK/ANKLE/FOOT, EXT |
| Product Code | ISW |
| Date Received | 2015-04-28 |
| Returned To Mfg | 2015-03-31 |
| Model Number | RKN130007 |
| Catalog Number | RKN130007 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OSSUR |
| Manufacturer Address | REYKJAVIK IC |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-04-28 |