MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH SYNGO RT THERAPIST 4.3.1_MR2; ACCELERATOR, LINEAR, MEDICAL

Model Number 8162815

Device Problem Incorrect Software Programming Calculations (1495)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Siemens' investigation into the reported issue is on-going and a supplemental report will be submitted upon completion.

Event Description

It was reported that siemens conducted an internal investigation and a non-conformity was found with 4.3.1_mr2 and aria as ois when the plan contains multiple iso centers and the initial setup beam is defined.The issue is shown in the following examples: example one would be if the starting point is (10, 10, 10), the initial setup beam is (5, 5, 5) and beam1 is set at (iso1), beam2 is set at (iso2), then the delta between iso2 and iso1 is (2,2,2).Example two would be in normal sequence the starting point is (10, 10, 10), after initial setup beam (15,15,15), beam1 is treated on (15,15,15) and beam2 is treated on (17,17,17).Example three would be in late resumption if the interruption happened after beam1 is completed, starting point is (10, 10, 10), after initial setup beam (15,15,15), beam2 is treated on (12,12,12) because the initial movement of (5,5,5) is ignored.However, if cone beam ct (cbct) is always performed for the first iso center, then the software works correctly.

Manufacturer Narrative

Investigation into the reported event showed that the previously described issue is a non-conformity that is relevant only with software version (b)(4).A future software version, (b)(4), is planned as the solution for the reported issue.

• Brand Name: SYNGO RT THERAPIST 4.3.1_MR2
• Type of Device: ACCELERATOR, LINEAR, MEDICAL
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; medical solutions; roentgenstrasse 19-21; kemnath, 95478 ; GM 95478
• Manufacturer (Section G): SIEMENS HEALTHCARE GMBH; medical solutions; roentgenstrasse 19-21; kemnath, 95478 ; GM 95478
• Manufacturer Contact: marlynne galloway ; 40 liberty boulevard; mail stop: 65-1a; malvern, PA 19355-9998 ; 6104486471
• MDR Report Key: 5320067
• MDR Text Key: 34934578
• Report Number: 2240869-2015-27964
• Device Sequence Number: 1
• Product Code: IYE
• Combination Product (y/n): N
• Reporter Country Code: LO
• PMA/PMN Number: K132935
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/08/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 8162815
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/08/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1