MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-01-17 for ARTROMOT K3 CPM K# manufactured by Djo Don Joy Orthopedics.
[1726695]
The resident stated that the cpm machine pushed her knee up to her chest. It caused the resident discomfort and it frightened her. The machine was set for 90 degrees but it went further than 90 degrees and caused her to be afraid. Dates of use: (b)(6) 2011. Diagnosis or reason for use: right total knee replacement.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5019072 |
| MDR Report Key | 1969312 |
| Date Received | 2011-01-17 |
| Date of Report | 2011-01-17 |
| Date of Event | 2011-01-14 |
| Date Added to Maude | 2011-02-01 |
| 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 | 0 |
| 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 | ARTROMOT K3 CPM |
| Generic Name | CONTINUOUS PASSIVE MOVEMENT MACHINE |
| Product Code | BXB |
| Date Received | 2011-01-17 |
| Model Number | K# |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DJO DON JOY ORTHOPEDICS |
| Manufacturer Address | TN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2011-01-17 |