MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1995-12-29 for DYNAMOMETER EXERCISE SYSTEM 900-220 manufactured by Biodex Medical Systems.
[17579]
Pt was being set-up on exercise machine for treatment of left foot/ankle. When attempting to set range of motion limits, the machine forcefully rotated in the counter-clockwise direction and then locked in that position.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 29708 |
| MDR Report Key | 29708 |
| Date Received | 1995-12-29 |
| Date of Report | 1995-12-23 |
| Date of Event | 1995-06-19 |
| Date Facility Aware | 1995-06-20 |
| Date Reported to FDA | 1995-12-30 |
| Date Reported to Mfgr | 1995-12-30 |
| Date Added to Maude | 1996-02-08 |
| 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 | DYNAMOMETER EXERCISE SYSTEM |
| Generic Name | EXERCISE MACHINE |
| Product Code | ISD |
| Date Received | 1995-12-29 |
| Model Number | 900-220 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | NO INFO |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 30795 |
| Manufacturer | BIODEX MEDICAL SYSTEMS |
| Manufacturer Address | P O BOX 702 SHIRLEY NY 11967 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1995-12-29 |