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

Model Number	11061648
Medical Device Problem Code	Use of Incorrect Control/Treatment Settings (1126)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Siemens has completed an investigation of the event.The root cause was determined to be user error.There are 2 recon jobs for the tomo scan.Fixed axial for the image orientation of the first recon job and "axial/coronal/sagittal" for the second recon job.Because the patient position is ffp, the rotation of the recon box is different between these 2 recon jobs.The operator wants to use the ¿copy recon volume¿ function to copy the recon box of the 1st fixed axial recon and pasted this to the 2nd multi recon job which has different rotation of recon box with the 1st recon job.Therefore, when applying the ¿copy recon volume¿ function from the 1st fixed axial recon to the 2nd multi recon job, the image had been rotated 180 degrees, however the left/right label on the image is also changed accordingly, which is correct to make sure it can support the user judgement.Unfortunately, in this case, it is clear that the operator didn¿t notice this and mixed up the left and right side of the anatomy image.1.For ¿copy recon volume¿ this was a designed workflow and it¿s already effective since va10.The explanation of this function is quite clear (the rotation property is applied) in the ifu doc c2-082b.621.01.03.02 (page 430).The properties of the recon box are applied, for example, its size and its rotation, while the image orientation of the target volume is kept.2.In all viewings the orientation and the left/right label was correctly marked.In the ifu doc c2-082b.621.01.03.02 (page 57) it also reminds the operator to review the generated result to avoid wrong diagnosis.3.This ¿copy recon volume¿ function with correct marked left/right labels on the image was widely used (about 19 million usage at 11,326 systems within 6 months) and this is the only case reported from the installed base.Assessment does not indicate a system failure or malfunction and no non-conformity was identified.
Event or Problem Description
It was reported to siemens that an adverse event occurred while operating the somatom go top (cn) ct system.The customer reported that a ureteric stent was inserted incorrectly due to mixing up the left and right side of the anatomy image.After realizing the mistake, the operator had another ureteric stent inserted into the correct side timely.There was no negative impact to the state of health of the patient involved other than a delay in completing the procedure.

• Brand Name: SOMATOM GO.TOP (CN)
• Common Device Name: SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
• Manufacturer (Section D): SIEMENS SHANGHAI, MEDICAL EQUIPMENT LTD.; 278 zhou zhu rd.; shanghai 20131 8; CH 201318
• Manufacturer (Section G): SIEMENS SHANGHAI, MEDICAL EQUIPMENT LTD.; 278 zhou zhu rd.; shanghai 20131 8; CH 201318
• Manufacturer Contact: meredith adams ; 40 liberty blvd.; malvern, PA 19355 ; 4843231631
• MDR Report Key: 21399358
• Report Number: 3003202425-2025-00001
• Device Sequence Number: 9312110
• Product Code: JAK
• UDI-Device Identifier: 04056869151595
• UDI-Public: (01)04056869151595
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K173632
• 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 Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/18/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 11061648
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/05/2025
• Initial Report FDA Received Date: 02/18/2025
• 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
• Usage of Device: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Other
• Patient Sex: Unknown