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

Model Number 8139789

Device Problem Unintended Movement (3026)

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

Event Date 12/06/2022

Event Type  malfunction  

Manufacturer Narrative

No logfiles have been provided for a technical investigation.Siemens local service engineer continues to monitor the site and the problem.Some parts have already been replaced as a precautionary measure.The spare parts consumption is monitored by an internal capa team.The root cause of the issue remains unclear.A supplemental report will be submitted if any additional information becomes available.

Event Description

Siemens became aware of a system malfunction on the artiste mv.On several occasions the gantry rotated in the wrong direction during an auto sequencing treatment without any error message displayed to the user.No injury has been reported to siemens.Nevertheless, a critical patient injury, in the event of a collision with the gantry, cannot be excluded completely.According to the system design, there is a safety measure in place.If the gantry moves in the wrong direction for more than 2 degrees, the interlock "controller 0" will become active and stop all further movements.However, in the reported case it could not be confirmed whether the interlock had been set.

Manufacturer Narrative

Siemens completed investigation of the reported issue.The technical investigation did not indicate any device malfunction.The system works as designed.The rotational direction is displayed to the user in advance, if the gantry start position is not exactly at 0 degree.The involved user has incorrect expectation of the siemens linac system behavior in comparison to the varian linac.

• Brand Name: ARTISTE MV
• Type of Device: ACCELERATOR, LINEAR, MEDICAL
• 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 ; liberty blvd 40; mc 65-1a; malvern, PA 19355 ; 4843234897
• MDR Report Key: 16034480
• MDR Text Key: 307168588
• Report Number: 3002466018-2022-56831
• Device Sequence Number: 1
• Product Code: IYE
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K072485
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8139789
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1