MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-06-10 for * LEG PRESS manufactured by Cybex International, Inc..
[2019826]
Patient was operating a leg press unit in an outpatient rehabilitation clinic. While in operation, the cable on the leg press broke resulting in the patient's legs falling off of the plate and jerking him forward. The patient indicated that he was okay at the time of the incident as well as before leaving the clinic. Biomed was called and the broken cable was verified. Replaced cable and unit worked fine. Contacting manufacturer to see why a cable that was crimped by the vendor would break at the connector end.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2132478 |
| MDR Report Key | 2132478 |
| Date Received | 2011-06-10 |
| Date of Report | 2008-07-16 |
| Date of Event | 2008-06-16 |
| Report Date | 2008-07-16 |
| Date Reported to FDA | 2011-06-10 |
| Date Added to Maude | 2011-06-17 |
| 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 | * |
| Generic Name | EXERCISER, NON-MEASURING |
| Product Code | ION |
| Date Received | 2011-06-10 |
| Model Number | LEG PRESS |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | PATIENT |
| Device Availability | Y |
| Device Age | 8 YR |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CYBEX INTERNATIONAL, INC. |
| Manufacturer Address | 10 TROTTER DRIVE MEDWAY MA 02053 US 02053 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-06-10 |