MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1995-07-28 for CYBEX ISOKINETIC EXERCISE MACHINE 350 - CYBEX manufactured by Cybex.
[14460]
Operator of device was preparing a pt to utilize co's isokinetic exercise machine in physicial therapy. When attempting to use the keyboard to program treatment, she sustained and injury from electrical shock, which caused a burn to the employees right forearm tissue.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 26341 |
| MDR Report Key | 26341 |
| Date Received | 1995-07-28 |
| Date Added to Maude | 1995-10-03 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CYBEX ISOKINETIC EXERCISE MACHINE |
| Generic Name | EXERCISE MACHINE |
| Product Code | IKK |
| Date Received | 1995-07-28 |
| Model Number | 350 - CYBEX |
| Device Availability | * |
| Device Age | * |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 27013 |
| Manufacturer | CYBEX |
| Manufacturer Address | 2100 SMITHTOWN AVE P.O. BOX 9003 RONKONKOMA LONG ISLAND NY 11779 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1995-07-28 |