MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH ARTISTE MV; MEDICAL CHARGED-PARTICLE RADIATION THERAPY SYSTEM

Model Number 8162815

Device Problem Device Handling Problem (3265)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/17/2022

Event Type  Injury  

Manufacturer Narrative

The provided savelogs were investigated by siemens.No malfunction of the rtt has been determined.Further investigations will be performed to evaluate possible measures to avoid re-occurrence.A supplemental report will submitted if additional information becomes available.Internal id # (b)(4).

Event Description

Siemens became aware of an incident with the artiste mv unit.Siemens was provided savelog files by the user.The analysis of the files showed that the user had loaded a patient with two plans (targets) from aria (ois) to rt therapist application (rtt).The user then selected the cbct beam from the second displayed plan (in the plan list, e.G."target 2").An image was acquired, calculated, and the offsets were applied.However, the user did not realize that the last used plan ("target 2") had moved to the top of the list in txvisualization; the user selected the tx beams of the original first plan, now displayed as a second plan ("target 1"), delivering an incorrect plan ("target 1") to the actual positioned isocenter (patient setup) of the"target 2".A physicist at the facility was able to adapt the plan afterwards for the last fraction accordingly.The failure resulted in a mistreatment of 4gy to a wrong location.The customer confirmed that no severe injury occurred.The reported event occurred in (b)(6).

Manufacturer Narrative

The root cause of the reported issue is known behavior.It is not considered a device malfunction, but a specific behavior of the system that may contribute to an incorrect treatment plan.The details of the behavior are explained in the customer safety advisory letter distributed to the users via an update instruction th001/21/s (reported under c&r # 2240869-11/30/2021-0020-c, res # 89228 in 2021).Siemens will improve the behavior of the rtt software and distribute new rtt software version 4.3.1_mr4 as soon as it becomes available.All affected customers will be reminded about this behavior and the upcoming software update via a customer safety advisory notice.These activities will be reported separately as a recall once released to the field.

• Brand Name: ARTISTE MV
• Type of Device: MEDICAL CHARGED-PARTICLE RADIATION THERAPY SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; roentgenstrasse 19-21; kemnath 95478 ; GM 95478
• Manufacturer (Section G): SIEMENS HEALTHCARE GMBH; roentgenstrasse 19-21; kemnath 95478 ; GM 95478
• Manufacturer Contact: anastasia sokolova ; 40 liberty blvd.; mc 65-1a; malvern, PA 19355 ; 6104486478
• MDR Report Key: 14642265
• MDR Text Key: 293631509
• Report Number: 3002466018-2022-29585
• Device Sequence Number: 1
• Product Code: IYE
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K072485
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 8162815
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/15/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other