MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2007-03-22 for EXACT COUCH * manufactured by Varian Medical Systems.
[606975]
Rt-1 was in the linac vault to set up the linac bed for a pt. During this time, rt-2 was assisting. At some point, rt-1 had her hand near the mechanical gear/adjustment mechanism and rt-2 began adjusting the bed unknowing of the status/position of rt-1. As a result, rt-1 had her finger caught in the mechanism and the mechanism severed her finger from the last knuckle up.
Patient Sequence No: 1, Text Type: D, B5
[7819668]
This incident has been recognized as user error by varian medical systems. Labeling placed on the couch, as well as in the user manual, provide instruction and hazard warnings (with respect to hand placement), varian is looking into a prevent action to prevent this pinch-point issue from happening in the future.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2914292-2007-00007 |
| MDR Report Key | 831268 |
| Report Source | 05,06 |
| Date Received | 2007-03-22 |
| Date of Report | 2007-03-01 |
| Date of Event | 2007-02-21 |
| Date Mfgr Received | 2007-03-01 |
| Device Manufacturer Date | 2000-04-01 |
| Date Added to Maude | 2007-03-28 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | DALE REYNOLDS |
| Manufacturer Street | 911 HANSEN WAY M/S C255 |
| Manufacturer City | PALO ALTO CA 94304 |
| Manufacturer Country | US |
| Manufacturer Postal | 94304 |
| Manufacturer Phone | 6504246640 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EXACT COUCH |
| Generic Name | PT POSITIONING TABLE |
| Product Code | JAI |
| Date Received | 2007-03-22 |
| Model Number | EXACT COUCH |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 818604 |
| Manufacturer | VARIAN MEDICAL SYSTEMS |
| Manufacturer Address | * PALO ALTO CA * US |
| Baseline Brand Name | EXACT COUCH |
| Baseline Generic Name | PT POSITIONING TABLE |
| Baseline Model No | EXACT COUCH |
| Baseline Catalog No | * |
| Baseline ID | REV. 20 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2007-03-22 |