MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-07-25 for CYBEX NORM ISOKINETIC UNIT 771CF6-1 manufactured by Cybex.
[17178659]
Pt was strapped on the cybex machine in the passive range of motion mode for left knee flexion and extension. When the machine was started it beat the pt's left knee back into flexion further than the anticipated range of motion before the emergency stop control could be activated. The mechanical stops were not set.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 112938 |
| MDR Report Key | 112938 |
| Date Received | 1997-07-25 |
| Date of Report | 1997-03-10 |
| Date of Event | 1997-03-07 |
| Date Facility Aware | 1997-03-07 |
| Report Date | 1997-03-12 |
| Date Reported to Mfgr | 1997-03-12 |
| Date Added to Maude | 1997-08-18 |
| 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 |
| 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 | CYBEX NORM ISOKINETIC UNIT |
| Generic Name | TESTING AND REHABILITATION SYSTEM |
| Product Code | IKK |
| Date Received | 1997-07-25 |
| Model Number | NORM |
| Catalog Number | 771CF6-1 |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 10 MO |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 93640 |
| Manufacturer | CYBEX |
| Manufacturer Address | 2100 SMITHTOWN AVE P.O. BOX 9003 RONKONKOMA, LI, NY 117799003 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1997-07-25 |