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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: VARIAN MEDICAL SYSTEMS, INC. TRUEBEAM EDGE; ACCELERATOR, LINEAR, MEDICAL
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VARIAN MEDICAL SYSTEMS, INC. TRUEBEAM EDGE; ACCELERATOR, LINEAR, MEDICAL Back to Search Results
Device Problem Self-Activation or Keying (1557)
Patient Problem Insufficient Information (4580)
Event Date 12/14/2020
Event Type  malfunction  
Event Description
Therapist took 2d/3d and applied shifts.Therapist centered couch for cbct (cone-beam computed tomography), took cbct, reviewed images with md, minimal shifts were recorded, and therapist rotated gantry to 0 then restored couch to iso.Couch lateral was supposed to land at 6.4, however, continued to 13.0 without being prompted by rtt (real time tomography).Therapist removed hand from motion enable once table was past 6, however, table was moving quickly.A cchu fault appeared but disappeared quickly prior to rtt being able to review it.Imaging panel was touching vac loc bag, but collision sensor did not go off.Patient was taken off table and engineering/physics was notified.Varian ticket was open.Engineering power cycled cchu board.
 
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Brand Name
TRUEBEAM EDGE
Type of Device
ACCELERATOR, LINEAR, MEDICAL
Manufacturer (Section D)
VARIAN MEDICAL SYSTEMS, INC.
911 hansen way
palo alto CA 94304
MDR Report Key11154173
MDR Text Key226268791
Report Number11154173
Device Sequence Number1
Product Code IYE
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 01/08/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/12/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/08/2021
Event Location Hospital
Date Report to Manufacturer01/12/2021
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Age25915 DA
Patient Weight93
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