MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2006-10-03 for EXACT COUCH NA manufactured by Varian Medical Systems.
[14868040]
When the radilogical tech tried to retract the couch top longitudinally to remove the pt from the couch, the tech pinched and broke the little finger of his left hand in a pinch point of the underside of the exact couch. The pinch point seemed to be the gap between the underside of the couch top and the lateral carriage.
Patient Sequence No: 1, Text Type: D, B5
[15227573]
H6: this incident has been recognized as user error by varian med systems. Labeling placed on the couch, as well as in the user manual, provide instruction and hazard warnings (with respect to hand placement), which help to ensure the safe operation of the equipment.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2914292-2006-00038 |
| MDR Report Key | 767173 |
| Report Source | 05,06 |
| Date Received | 2006-10-03 |
| Date of Report | 2006-09-08 |
| Date of Event | 2006-09-07 |
| Date Mfgr Received | 2006-09-15 |
| Date Added to Maude | 2006-10-06 |
| 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 | 2006-10-03 |
| 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 | 755073 |
| Manufacturer | VARIAN MEDICAL SYSTEMS |
| Manufacturer Address | * * * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2006-10-03 |