MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2006-11-03 for EXACT COUCH NA manufactured by Varian Medical Systems.
[16027189]
Four (4) therapist were setting up a pt for treatment. They released the longitudinal locks, and manually moved the pt into the treatment field. One of the therapists was on the klystron side of the table at the foot of the pt. As the longitudinal carriage was moved into the field, the therapist's left ring finger was caught between the lateral carriage assembly and the stretcher assembly. The therapist needed surgery on her finger and was hospitalized due to this injury.
Patient Sequence No: 1, Text Type: D, B5
[16155372]
This incident has been recognized as user error by varian medical systems. Labeling placed on the couch, as well as in the user and safety manual, provide instruction and hazard warnings (with respect to hand placement), which helps to ensure the safe operation of the equipment.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2914292-2006-00040 |
| MDR Report Key | 777090 |
| Report Source | 05,06 |
| Date Received | 2006-11-03 |
| Date of Report | 2006-10-23 |
| Date of Event | 2006-10-17 |
| Date Mfgr Received | 2006-10-24 |
| Device Manufacturer Date | 2000-09-01 |
| Date Added to Maude | 2006-11-07 |
| 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 | 2006-11-03 |
| Model Number | EXACT COUCH |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 764868 |
| Manufacturer | VARIAN MEDICAL SYSTEMS |
| Manufacturer Address | * * * |
| 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. Hospitalization; 2. Other | 2006-11-03 |