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

Model Number 11061640

Device Problem Computer Software Problem (1112)

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

Event Date 11/15/2022

Event Type  malfunction  

Event Description

It was reported to siemens that a malfunction occurred while operating the somatom go.Top ct system.Siemens was notified about a customer issue using the myneedle guide ct intervention application.On (b)(6) 2022, the image orientation was flipped when the customer used the "move to" selected slice position.The customer recognized the flipped images and additional i-fluoro images were taken during the procedure to ensure angles in the correct direction.There is no report of impact to the state of health of any patient or user involved.

Manufacturer Narrative

Siemens has completed a detailed technical investigation of the issue and 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 above-mentioned 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 is preparing a customer safety advisory notice to address this to all users of the affected application licenses.The csan and its technical solution will be reported according to 21cfr806.

• Brand Name: SOMATOM GO.TOP
• Type of Device: 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: 16003812
• MDR Text Key: 308538636
• Report Number: 3004977335-2022-54342
• Device Sequence Number: 1
• Product Code: JAK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K211373
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 12/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 11061640
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 11/23/2022
• 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