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

Model Number 8162815

Device Problem Data Problem (3196)

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

Event Date 10/15/2015

Event Type  malfunction  

Manufacturer Narrative

Siemens' initial assessment of the issue on october 20, 2015 was deemed a non-critical display issue only.Following the completion of a full investigation of results, and root cause analysis that concluded on november 10, 2015, this issue is now considered to be a reportable event as the potential exists for system malfunction.Investigation into the reported issue shows that the user tried to load and unload the patient multiple times for unknown reasons.During this workflow a cache was not deleted and an incorrect internal identifier attached to the image, which led to the display of an incorrect patient name.In turn, the image was stored under the displayed patient´s folder.The reference image used in adaptive targeting would then be the image of the incorrect patient, which could lead to wrong offset values for patient positioning.Siemens has not received any reports of mistreatment or injury to a patient.The root cause of this software error could not be identified.It is assumed that there was a signal timing-problem during the multifold patient load/unload process.In the present case the user immediately recognized the incorrect patient name.The complaint behavior was not reproducible and has been identified as an isolated incident.Considering this, no corrective action is initiated.

Event Description

The customer notified siemens on (b)(6) 2015 that when they completed setup images and verification images, two patients were mixed up.Reportedly, the customer loaded a patient, that was previously treated, from candelis.Setup and verification images were completed and the patient was treated.After treatment the customer closed the patient on the rt therapist (rtt).The customer loaded another patient, that was not previously treated, directly from candelis.The treatment plan was loaded and setup images were completed however the images are labeled with the name of the patient that was previously treated.In a case where the reported mixup of patient reference images occurs after the described special workflow, it is possible that the user may not be aware that the issue has occurred, which could lead to a wrong offset calculation for patient positioning.However, there is no report of mistreatment or injury to a patient.The issue occurred shortly after the rt therapist was updated to version 4.3.1 mr2.The customer performed the same workflow on another artiste with an older version of rtt on-site without any problem.This reported issue occurred in (b)(6).

• Brand Name: SYNTO 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: 5276087
• MDR Text Key: 33472480
• Report Number: 2240869-2015-24293
• Device Sequence Number: 1
• Product Code: IYE
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K132935
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 11/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2015
• 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?: Yes
• Date Manufacturer Received: 10/15/2015
• 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