MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2012-04-27 for VARIAN B-130 RAD-60 manufactured by Varian Medical Systems.
[16102357]
Varian received notification that a b-130/rad-60 x-ray tube assembly had failed. During the first procedure of the morning, oil leaked from the x-ray tube onto the pt's skirt. There was no injury to the pt.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1717855-2012-00001 |
| MDR Report Key | 2556484 |
| Report Source | 06 |
| Date Received | 2012-04-27 |
| Date of Report | 2012-03-27 |
| Date of Event | 2012-03-27 |
| Date Mfgr Received | 2012-03-27 |
| Device Manufacturer Date | 2010-02-01 |
| Date Added to Maude | 2012-09-17 |
| 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 | LINDA CHATWIN |
| Manufacturer Street | 1678 SOUTH PIONEER ROAD |
| Manufacturer City | SALT LAKE CITY UT 84104 |
| Manufacturer Country | US |
| Manufacturer Postal | 84104 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VARIAN |
| Generic Name | X-RAY TUBE HOUSING ASSEMBLY |
| Product Code | ITY |
| Date Received | 2012-04-27 |
| Returned To Mfg | 2012-04-10 |
| Model Number | B-130 |
| Catalog Number | RAD-60 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | VARIAN MEDICAL SYSTEMS |
| Manufacturer Address | SALT LAKE CITY UT US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-04-27 |