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

Model Number 8139789

Device Problem Failure to Recalibrate (1517)

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

Event Date 09/25/2020

Event Type  malfunction  

Manufacturer Narrative

Siemens has completed a technical investigation of the event.No failure in the auto-registration algorithm and no failure in the rtt application were found.The quality assurance (qa) check on site found that a geometrical calibration of the cbct (3d geometry correction followed by: patient positioning qa) was needed.According to the user manual the qa check "3d geometry correction followed by: patient positioning qa" is required at least every 6 months.

Event Description

It was reported to siemens by the customer that they observed a large offset shift with 5cm or more which was calculated by the auto-registration in rt therapist (rtt) application within cone beam ct (cbct) set up in the linac system.The customer then acquired 2d setup images with the same patient position and the shift was in a normal value (1-2mm).This observation re-occurred with other (smaller) shifts intermittently.The described difference in calculated offsets was confirmed.Cbcts from two occurrences were compared and it was found that the image quality in both datasets are weak as there is a lack of contrast there and the bones are barely visible.No mistreatment or injury of a person has been reported.The use of images with a lack of contrast could lead to incorrect auto-registration resulting in incorrect offset calculations.If not observed by the user it could lead to a mistreatment with dose to a wrong location with the potential to lead to severe injury of the patient.The reported event occurred in (b)(6).

• 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: marlynne galloway ; 40 liberty blvd.; ms: 65-1a; malvern, PA 19355 ; 6104486741
• MDR Report Key: 10741612
• MDR Text Key: 241074204
• Report Number: 3002466018-2020-48642
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 10/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2020
• 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?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/28/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1