MAUDE Adverse Event Report: SIEMENS SHANGHAI MEDICAL EQUIPMENT LTD. SOMATOM GO.TOP (CN); SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED

Model Number 11061648

Device Problem Computer Software Problem (1112)

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

Event Date 01/09/2023

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 that the image labeling "head centre feet" was incorrect on images during the procedure despite the correct patient position selected.The customer turned off mirroring of interventional protocols and the reconstructed images were normal again.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 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.Siemens is currently working on a permanent solution for this malfunction and the solution will be distributed as a software update.As an immediate action, siemens has distributed a customer safety advisory notice to address this error to all users of the affected application licenses.This action was reported to the fda according to 21cfr806 on(b)(6)2022, under report number 2240869-12/22/2022-0022-c (res#91481, ct083/22/s).

• Brand Name: SOMATOM GO.TOP (CN)
• Type of Device: SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
• Manufacturer (Section D): SIEMENS SHANGHAI MEDICAL EQUIPMENT LTD.; 278 zhou zhu rd.; shanghai, china 20131 8; CH 201318
• Manufacturer (Section G): SIEMENS SHANGHAI MEDICAL EQUIPMENT LTD.; 278 zhou zhu rd.; shanghai, china 20131 8; CH 201318
• Manufacturer Contact: meredith adams ; 40 liberty blvd.; malvern, PA 19355 ; 4843231631
• MDR Report Key: 16313558
• MDR Text Key: 309598672
• Report Number: 3003202425-2023-62027
• Device Sequence Number: 1
• Product Code: JAK
• UDI-Device Identifier: 04056869151595
• UDI-Public: 04056869151595
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K211373
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 02/07/2023

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
• Device Operator: Health Professional
• Device Model Number: 11061648
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/31/2023
• Initial Date FDA Received: 02/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: RES# 91481
• Patient Sequence Number: 1