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.
[2559458]
A patient was placed on the cpm (continuous passive motion) machine following a total knee replacement. While using the machine the patient began to feel tingling and shock from the machine. The machine was removed from service and replaced. ======================manufacturer response for cpm machine, (brand not provided) (per site reporter). ======================they removed the machine, took it with them and investigated the report.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2427213 |
| MDR Report Key | 2427213 |
| Date Received | 2011-09-29 |
| Date of Report | 2011-09-29 |
| Date of Event | 2011-05-05 |
| 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 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 |