MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2017-08-17 for PATIENT POSITIONING SYSTEM 7755-11 NOT APPLICABLE manufactured by Forte Automation Systems, Inc.
[83155209]
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.
Patient Sequence No: 1, Text Type: N, H10
[83155210]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003900998-2017-00001 |
| MDR Report Key | 6802480 |
| Report Source | DISTRIBUTOR |
| Date Received | 2017-08-17 |
| Date of Report | 2017-07-19 |
| Date of Event | 2017-05-24 |
| Date Mfgr Received | 2017-07-19 |
| Device Manufacturer Date | 2013-07-01 |
| Date Added to Maude | 2017-08-17 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. PHIL REECE |
| Manufacturer Street | 8155 BURDEN ROAD |
| Manufacturer City | MACHESNEY PARK IL 61008 |
| Manufacturer Country | US |
| Manufacturer Postal | 61008 |
| Manufacturer Phone | 8156332300 |
| Manufacturer G1 | FORTE AUTOMATION SYSTEMS, INC |
| Manufacturer Street | 8155 BURDEN ROAD |
| Manufacturer City | MACHESNEY PARK IL 61008 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 61008 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NOT APPLICABLE |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PATIENT POSITIONING SYSTEM |
| Generic Name | PATIENT POSITIONING SYSTEM |
| Product Code | JAI |
| Date Received | 2017-08-17 |
| Model Number | 7755-11 |
| Catalog Number | NOT APPLICABLE |
| Lot Number | NOT APPLICABLE |
| Operator | SERVICE PERSONNEL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | FORTE AUTOMATION SYSTEMS, INC |
| Manufacturer Address | 8155 BURDEN RD MACHESNEY PARK IL 61115 US 61115 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-08-17 |