MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-09-29 for * manufactured by Orthotek.
[16672822]
A patient was placed on the cpm (continuous passive motion) machine following total knee replacement. She reported to the staff that the machine had shocked her. The patient was switched to another machine. This machine also shocked her. The third machine she reported no shocks. ======================manufacturer response for continuous passive motion, (brand not provided) (per site reporter)======================the machines were removed from service and they began an investigation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2427214 |
| MDR Report Key | 2427214 |
| Date Received | 2011-09-29 |
| Date of Report | 2011-09-29 |
| Date of Event | 2011-05-24 |
| Report Date | 2011-09-29 |
| Date Reported to FDA | 2011-09-29 |
| Date Added to Maude | 2012-01-25 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | * |
| Generic Name | EXERCISER, POWERED |
| Product Code | BXB |
| Date Received | 2011-09-29 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ORTHOTEK |
| Manufacturer Address | 1980 NW 94TH ST. SUITE D DES MOINES IA 50325116 US 50325 1162 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-09-29 |