MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,06 report with the FDA on 2007-10-19 for EXACT COUCH NA manufactured by Varian Medical Systems.
[734870]
Operator a was holding the couch at the back of couch top- fingers in-between the tabletop edge and movable carbon fiber rail. Operator b was assisting in moving the couch top with pt loaded in the longitudinal direction. With operator a's first fingers in the location stated above, a pinch point existed between the moving carriage and the stationary lateral base. The couch top was moved in towards the stand too fast and broke the bone on the finger of therapist a.
Patient Sequence No: 1, Text Type: D, B5
[8120590]
This incident is recognized as use 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), which help to ensure the safe operation of the equipment. However, capa has been opened to investigate possible product improvement to further mitigate this documented risk.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2914292-2007-00039 |
| MDR Report Key | 930043 |
| Report Source | 01,06 |
| Date Received | 2007-10-19 |
| Date of Report | 2007-10-08 |
| Date of Event | 2007-10-08 |
| Date Mfgr Received | 2007-10-11 |
| Device Manufacturer Date | 1997-03-01 |
| Date Added to Maude | 2007-10-25 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | DALE REYNOLDS |
| Manufacturer Street | 911 HANSEN WAY |
| Manufacturer City | PALO ALTO CA 95117 |
| Manufacturer Country | US |
| Manufacturer Postal | 95117 |
| Manufacturer Phone | 6504246640 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EXACT COUCH |
| Generic Name | PATIENT POSITIONING TABLE |
| Product Code | JAI |
| Date Received | 2007-10-19 |
| Model Number | EXACT COUCH |
| Catalog Number | NA |
| Lot Number | NA |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 904306 |
| Manufacturer | VARIAN MEDICAL SYSTEMS |
| Manufacturer Address | 3100 HANSEN WAY PALO ALTO CA 94304 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-10-19 |