MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-03-02 for KIN COM 125E PLUS manufactured by Chattanooga Group, Inc..
[8353]
The pt was exercising her hamstring muscles in the prone position on the device. The range of motion was set via the computer from approx 10-80 degrees flexion. The pt was set up by the physical therapist without incident. However, while exercising, the pt noticed something felt loose. She called a physical therapist assistant and when the assistant found that the lever arm had become loose, she tightened it. She then restarted the program and the machine malfunctioned, pulling the pt's leg quickly and sharply into hyperextension. The pt reported the screen flashed to a different program. The assistant quickly stopped the device and several therapists assisted her in unstrapping the pt's leg and assisting her off the unit. It is unknown whether the mechanical stops, which were not put in, would have stopped the lever arm.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1000957 |
| MDR Report Key | 11838 |
| Date Received | 1994-03-02 |
| Date of Report | 1994-02-14 |
| Date of Event | 1994-02-09 |
| Date Added to Maude | 1994-03-07 |
| 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 |
| Reporter Occupation | PHYSICAL THERAPIST |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | KIN COM |
| Generic Name | ISOKINETIC EXERCISE AND TESTING |
| Product Code | IKK |
| Date Received | 1994-03-02 |
| Model Number | 125E PLUS |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 11838 |
| Manufacturer | CHATTANOOGA GROUP, INC. |
| Manufacturer Address | HIXSON TN 37343 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Other | 1994-03-02 |