MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1996-02-06 for KINETRON-CYBEX STAIRMASTER TYPE manufactured by Cybex Corp..
[22540]
Foot pedals gave way while pt was standing on them. Pt crashed to floor while in vertical position causing increased forces through bilateral lower extremities and lumbar spine. Pt stated immediate onset of low back pain. Clinical engineering has identified belt failure contributing to the loss of hydraulic pressure to the pedals.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 31841 |
| MDR Report Key | 31841 |
| Date Received | 1996-02-06 |
| Date of Report | 1996-01-22 |
| Date of Event | 1996-01-18 |
| Date Facility Aware | 1996-01-18 |
| Report Date | 1996-01-22 |
| Date Added to Maude | 1996-04-10 |
| 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 | KINETRON-CYBEX STAIRMASTER TYPE |
| Generic Name | STAIRMASTER |
| Product Code | ISD |
| Date Received | 1996-02-06 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | * |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 32981 |
| Manufacturer | CYBEX CORP. |
| Manufacturer Address | 2100 SMITHTOWN AVE RONKONKOMA NY 11779 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1996-02-06 |