MAUDE Adverse Event Report: FORTE AUTOMATION SYSTEMS, INC PATIENT POSITIONING SYSTEM

Model Number 7755-11

Device Problems Computer Software Problem (1112); Device Stops Intermittently (1599); Application Program Problem (2880); Device Operates Differently Than Expected (2913); Output Problem (3005); Programming Issue (3014)

Patient Problem No Patient Involvement (2645)

Event Date 05/24/2017

Event Type  malfunction  

Manufacturer Narrative

Forte automation investigation results: communications between the patient positioning system and the accuracy filter can periodically fail.During this time the patient positioning system should not move.It was found that for certain software versions the patient positioning system will move to an uncompensated position that can be off a few millimeters in z.Forte automation is investigating a correction for these issues.All further information will be reported under 21 cfr 806.10.No additional follow-up to this report is anticipated.

Event Description

Varian medical systems informed forte automation systems on july 19, 2017 of a finding at a customer site during commissioning of the proton system.They noted sporadic position inaccuracy of the robotic treatment table during tests at the psi gantry 3 on (b)(6) 2017.The treatment table was moved to a 95-deg yaw position.The table motion was completed with the proton therapy controller [ptc] displaying all coordinates for the intended position.However, the position of a laser tracker target was found to be 14 millimeters off the intended position (isocenter).After moving the table to a different position and going back to exactly the same 95-deg position, the laser tracker target was found at isocenter within the expected tolerances.Varian investigation of the issue was unable to identify a problem with the varian proton therapy controller and questioned whether the problem was with the forte automation patient positioning system.

• Brand Name: PATIENT POSITIONING SYSTEM
• Type of Device: PATIENT POSITIONING SYSTEM
• Manufacturer (Section D): FORTE AUTOMATION SYSTEMS, INC; 8155 burden rd; machesney park IL 61115
• Manufacturer (Section G): FORTE AUTOMATION SYSTEMS, INC; 8155 burden road; machesney park IL 61008
• Manufacturer Contact: phil reece ; 8155 burden road; machesney park, IL 61008 ; 8156332300
• MDR Report Key: 6802480
• MDR Text Key: 83155209
• Report Number: 3003900998-2017-00001
• Device Sequence Number: 1
• Product Code: JAI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K122413
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 07/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Service Personnel
• Device Model Number: 7755-11
• Device Catalogue Number: NOT APPLICABLE
• Device Lot Number: NOT APPLICABLE
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/19/2017
• Initial Date FDA Received: 08/17/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: NOT APPLICABLE
• Patient Sequence Number: 1