MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH ARTISTE MV; ACCELERATOR, LINEAR, MEDICAL

Model Number 08139789

Device Problems Computer Software Problem (1112); Device Operates Differently Than Expected (2913); Positioning Problem (3009)

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

The customer informed siemens on november 7, 2015 that after performing an upgrade under recall z-5812-2015, there is no pause on rt therapist by default as it was with software version 4.2.110.So when the gantry and the table are to be moved, the movement is done automatically without customer intervention (on rtt 4.2.110 they need to hit f12 and then keep pressing alt+enable to rotate the table).Reportedly, on (b)(6) 2015 the customer noticed that at first beam the machine had been configured with the gantry at 315 degrees and the table was configured at 90 degrees.The next beam configuration was the gantry at 86 degrees and the table at 0 degrees.When the first beam was completed the gantry started to move automatically while the table was still at 90 degrees.When the operator saw that the gantry crossed 0 degrees and was still moving with the table still at 90 degrees, they pressed the pause button on the control console and the movement stopped.Then they manually moved the table to 0 degrees and manually moved the gantry to 86 degrees.There is no report of mistreatment or injury to a patient.This reported issue occurred in (b)(6).

Manufacturer Narrative

Siemens' investigation into the reported issue has determined that the system worked as specified.No unsafe automatic motion in treatment mode was found.The hardware (control console and linac) and software works as specified however the previously implemented feature of automatically inserted pauses in case of different table iso angles within an autosequence has been eliminated.This issue will be fixed with a new software version (syngo rt therapist 4.3.1_mr3) in the future.

• Brand Name: ARTISTE MV
• 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 ; liberty 40 boulevard; mail stop: 65-1a; malvern, PA 19355-9998 ; 6104486471
• MDR Report Key: 5308029
• MDR Text Key: 34593434
• Report Number: 2240869-2015-05900
• Device Sequence Number: 1
• Product Code: IYE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K132935
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Service Personnel
• Type of Report: Initial,Followup
• Report Date: 11/07/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 08139789
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/19/2016
• Was Device Evaluated by Manufacturer?: No
• 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
• Patient Outcome(s): Disability