MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH SYNGO RT THERAPIST 4.3.1 MR2; ACCELERATOR, LINEAR, MEDICAL

Model Number 8162815

Device Problem Device Displays Incorrect Message (2591)

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

Siemens was notified on (b)(6) 2015 that the customer recently received an upgrade to syngo rt therapist 4.3.1 mr2 and reported that there is no longer a hard coded pause with a message about moving components if any beam has changes/differences in parameters (example: different table isocenter positions 0 to 270) from one beam to another in an auto-sequence group.But, in mr2 there is no pause or message for the customer to be aware of moving parts; treatment continues without pause.In rare cases of extreme patient positioning there is potential for collision.However, there is no report of injury or mistreatment to a patient.

Manufacturer Narrative

Siemens' hardware investigation shows that the described behavior of the linac control console works as specified.However, the syngo rt therapist 4.3.1_mr2 software update introduced a change regarding the handling of relative/absolute table setup whereby the system no longer generates a warning message about moving components.A customer advisory notice dated january 27, 2016 was distributed to customers, informing them of the workaround to add a manual pause between the treatment fields in order for the system to interrupt/pause the treatment to move the table and the gantry manually.The reported software behavior will be corrected in a future update, syngo rt therapist 4.3.1_mr3.

• 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; roentgenstrasse19-21; kemnath, 95478 ; GM 95478
• Manufacturer Contact: marlynne galloway ; 40 liberty boulevard; mail stop: 65-1a; malvern, PA 19355-9998 ; 6104486471
• MDR Report Key: 5241435
• MDR Text Key: 32102364
• Report Number: 2240869-2015-24800
• 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,user f
• Reporter Occupation: Service Personnel
• Type of Report: Initial,Followup
• Report Date: 10/22/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8162815
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/02/2016
• 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