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

Model Number 8162815

Device Problems Improper or Incorrect Procedure or Method (2017); Computer Operating System Problem (2898)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 12/21/2016

Event Type  malfunction  

Manufacturer Narrative

The investigation is on-going and a supplemental report will be submitted upon completion.(b)(6).

Event Description

The customer informed siemens on (b)(6) 2016 that the rt therapist 4.3.1 used incorrect isocenter coordinates of 0/0/0 during a cone beam ct (cbct) matching procedure instead of the isocenter values provided by mosaiq.The user recognized the deviation in the isocenter coordinates and compared the isocenter coordinates of the treatment plan with the rt therapist data after acquiring the cbct.On february 21, 2017 it was confirmed during investigation that if the user had not recognized the deviation, the dose would have been delivered to a wrong location.There is no report of mistreatment or injury to a patient.This reported issue occurred in (b)(6).

Manufacturer Narrative

In siemens' review of the logfiles provided it is evident that the planning isocenter coordinates were changed to (0,0,0) during the manual registration by an unknown software error.We are not able to identify the reason why this change happened on this system.The investigation of the provided treatment planning data of the affected patient showed that it did not contain a correctly defined planning isocenter.The x, y, z values of the defined planning isocenter were not matching the beam isocenter therefore rt therapist generated a new one.If the planning isocenter is properly defined, adaptive targeting will not generate a planning isocenter on its own and the reported error situation may not happen.It is reasonable to assume that because the user defines the planning isocenter correctly, the user will recognize a large isocenter deviation and correct it.There have been no similar issues reported.The reported issue is therefore considered to be an isolated incident.Data and log files investigated.

• Brand Name: RT THERAPIST 4.3.1_MR2
• Type of Device: ACCELERATOR, LINEAR, MEDICAL
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH AT-RO; medical solutions; roentgen strasse 19-21; kemnath, 95478 ; GM 95478
• Manufacturer (Section G): SIEMENS HEALTHCARE GMBH AT-RO; medical solutions; roentgen strasse 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: 6479944
• MDR Text Key: 72673952
• Report Number: 2240869-2017-65439
• Device Sequence Number: 1
• Product Code: IYE
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K142434
• 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: 02/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/21/2017
• Initial Date FDA Received: 04/11/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/29/2017
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1