FDA.reportPublic FDA data

MAUDE MDR 1993438

MDR report key
1993438
Report number
1717855-2011-00001
Event key
0
Event type
3
Date of event
2010-09-24
Date received
2011-02-11
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Contact
LINDA CHATWIN
Address
1678 SOUTH PIONEER ROAD SALT LAKE CITY UT 84104 US
Phone
801-801-8019
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1VARIANX-RAY TUBE HOUSING ASSEMBLYVARIAN MEDICAL SYSTEMSITYB-130RAD-60Y Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12011-02-1101. O

Event Narratives#

D

Patient 1

THE INITIAL ANALYSIS SHOWED THAT THE ANODE BROKE APART AND CAUSED THE DAMAGE TO THE WINDOW RESULTING IN THE OIL LEAK.

N

Patient 1

(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.