MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH-CT SOMATOM X.CITE; SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED

Model Number	11330001
Medical Device Problem Code	Computer Software Problem (1112)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/17/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Siemens has completed a detailed technical investigation of the issue which revealed a device malfunction.The order of the orientation labels "head", "center", and "feet" in the axial thick slice segments are erroneously swapped in the following two cases: if the recon parameter "image order" is changed by the user from the default setting "head to feet" to "feet to head", or if the recon parameter "mirroring" is changed by the user from the default setting "none" to any other value, this influences the parameter "image order", which is switched from the default setting "head to feet" to "feet to head" so that the abovementioned condition applies.As a result, the head segment may mistakenly be labeled as "feet" and vice versa.If the user does not use anatomic landmarks and/or the shown images, and only focuses on the wrong orientation labels to determine the direction in which the needle must be tilted (towards the head or towards the feet), this could lead to the incorrect placement and angulation of the needle, resulting in potential unwanted damage to sensitive anatomical structures.In addition, if the "move to selected axial slice position" functionality is used to position the patient table for the next scan, and the user's selection of segment is based on the incorrect orientation label, this could lead to a scan being performed at the wrong position.To avoid a potential risk the customer should set the recon parameter "image order" to head to feet".Currently, siemens is working on a permanent solution for this malfunction and the solution will be distributed as a software update.As an immediate action, siemens has sent a customer safety advisory notice to address this to all users with the affected application licenses.The csan was reported according to 21cfr806 (fda# 2240869-12/22/2022-0021-c/ res# 91481).The affected customer received the csan on january 19, 2023 and was aware of the malfunction.
Event or Problem Description
It was reported to siemens that a malfunction occurred while operating the somatom x.Cite ct system.A customer reported an issue while using the myneedle guide ct intervention application on (b)(6) 2023.The image orientation was flipped when the customer attempted to mirror the imaging using a non-default position.There is no report of impact to the state of health of any patient or user involved.

• Brand Name: SOMATOM X.CITE
• Common Device Name: SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH-CT; siemensstr. 1 -or-; rittigfeld 1; forchheim, germany 91301 ; GM 91301
• Manufacturer (Section G): SIEMENS HEALTHCARE GMBH-CT; siemensstr. 1 -or-; rittigfeld 1; forchheim, germany 91301 ; GM 91301
• Manufacturer Contact: meredith adams ; 40 liberty blvd.; malvern, PA 19355 ; 4843231631
• MDR Report Key: 16654357
• Report Number: 3004977335-2023-67768
• Device Sequence Number: 6606994
• Product Code: JAK
• UDI-Device Identifier: 04056869231044
• UDI-Public: 04056869231044
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K211373
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Other
• Remedial Action: Notification,Inspection,Recall
• Type of Report: Initial
• Report Date (Section B): 03/31/2023

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
• Operator of Device: Health Professional
• Device Model Number: 11330001
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/17/2023
• Initial Report FDA Received Date: 03/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 2240869-12/22/2022-0021
• Patient Sequence Number: 1
• Patient Sex: Unknown