MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2011-02-11 for VARIAN B-130 RAD-60 manufactured by Varian Medical Systems.
[1711686]
The initial analysis showed that the anode broke apart and caused the damage to the window resulting in the oil leak.
Patient Sequence No: 1, Text Type: D, B5
[8954284]
(b)(4) was returned from (b)(6), after being in service for three weeks, for an oil leak. The window in the tube was broken allowing the oil to leak. The tube was returned to varian and analyzed. The initial analysis showed that the target broke apart and caused the damage to the window resulting in the oil leak. The focal spot for this tube had fold over. Portions of the track were melted and have cracks. This could be a result of the fold-over in the focal spot and/or the customer running this tube beyond its specification. There were no stationary melts on the track and the bearing rotated freely. Sometimes target fractures occur when a cold target is exposed to a high power shot. The evidence shows that the target was not warmed up when the failure occurred because there were no carbon deposits on the target. This was also confirmed by the system log files. Varian's customer specification for this tube type does not require a warm-up. There is evidence that the filaments were not on at the time of failure because they were not oxidized. This means that the failure occurred before or after an exposure and that the vacuum did not leak. The resistance measurements of the stator leads were within the limits of the specification. The electrical connectors and the feed through had good connection and wired to the correct locations. No other problem was found with the other components. The target was sent out to an outside lab for a fracture analysis to confirm the location of where the failure originated. These lab results show that the failure initiated below the target track. A test was conducted internally to see if similar track damage could be caused to a different tube while running at the maximum tube limits. The only way that cracks and melts could be created on the track was by running beyond the ratings of the tube. In conclusion, we have verified that at the correct rotational speed the focal spot on this tube would not cause the track damage seen, and we can conclude that the tube was operated outside the ratings. This could be through insufficient rotational speed or overpower. Misuse of the tube could not be confirmed from the logs that were provided. It is varian's recommendation that such information be available in the future when a failure occurs.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1717855-2011-00001 |
| MDR Report Key | 1993438 |
| Report Source | 00 |
| Date Received | 2011-02-11 |
| Date of Report | 2010-09-29 |
| Date of Event | 2010-09-24 |
| Date Mfgr Received | 2010-09-29 |
| Device Manufacturer Date | 2010-03-01 |
| Date Added to Maude | 2012-05-23 |
| 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 |
| Manufacturer Phone | 8019735158 |
| Single Use | 3 |
| Remedial Action | RL |
| 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 | 2011-02-11 |
| Returned To Mfg | 2010-11-04 |
| Model Number | B-130 |
| Catalog Number | RAD-60 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| 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 | 1. Other | 2011-02-11 |