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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: VARIAN MEDICAL SYSTEMS, INC. TRUEBEAM; ACCELERATOR, LINEAR, MEDICAL
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VARIAN MEDICAL SYSTEMS, INC. TRUEBEAM; ACCELERATOR, LINEAR, MEDICAL Back to Search Results
Model Number 2.5
Device Problem No Display/Image (1183)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/09/2018
Event Type  malfunction  
Event Description
During treatment, we experienced a collimator fault.We entered home screen for the linear accelerator and reinitialized the mlc's.When we returned to the treatment screen, it did not display what was treated.The plan was sent back to mosaiq emr and no dose or treatment parameters were recorded.Physics notified.Patient was removed from the treatment room.Physicist was able to review the log file on the linear accelerator and retrieve the data.Physicist manually entered the treatment data.Patient was able to complete the remainder of his treatment.Varian notified.
 
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Brand Name
TRUEBEAM
Type of Device
ACCELERATOR, LINEAR, MEDICAL
Manufacturer (Section D)
VARIAN MEDICAL SYSTEMS, INC.
911 hansen way
palo alto CA 94304
MDR Report Key7629652
MDR Text Key112043044
Report Number7629652
Device Sequence Number1
Product Code IYE
UDI-Device Identifier00899475002004
UDI-Public(01)00899475002004
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 05/31/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/22/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number2.5
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA05/31/2018
Event Location Hospital
Date Report to Manufacturer05/31/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Type of Device Usage N
Patient Sequence Number1
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