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

Model Number	11061648
Medical Device Problem Codes	Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Abrasion (1689)
Date of Event	06/27/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Siemens has completed an investigation of the event.The root cause was determined to be a user error.During investigation it was found that this was a patient with unclear consciousness, however, the technician did not use restraint straps to fix him, and the patient lifted his knee during scan.After phs horizontal entering into the gantry, the raised knee exerted strong pressure on the plexi ring.As a result, the plexi ring was deformed by the top pressure, and then the rotation parts inside the gantry and the deformed parts of the plexi ring were scratched, which caused the plexi ring to be damaged.The patient's knee had a minor abrasion which was disinfected with iodine.No additional medical treatment was needed.The plexi ring was fixed in the gap between the front and rear cover, which is designed according to iec 60601-1:2012, cl.15.3 and passes related tests by a third party recognized by nmpa.There is no special requirement for the position of the seams.The strength of all parts of the plexi ring, including the seams, meets the requirements of relevant regulations.There is no design defect regarding plexi ring of gantry.Based on the operator manual, c2-082b-c.621.02, it is clearly indicated with the following safety information and instruction that the patient needs to be fixed on the table, and the operator needs to observe the patient during the measurement to avoid injury to the patient.A siemens service engineer replaced the plexi ring and the system was returned to clinical use.Assessment does not indicate a system failure or malfunction, and no non-conformity was identified.This report has been submitted with an abundance of caution.
Event or Problem Description
It was reported to siemens that an adverse event occurred while operating the somatom go.Top ct scanner.During an examination, the patient exerted force on the plexi ring of the system with his knee, which was hit by the rotating components inside the gantry, causing the plexi ring to tear off.The examination was immediately terminated, and the patient's knee was checked.The patient's knee had a minor abrasion which was disinfected with iodine.No additional medical treatment was needed, and we are unaware of any further impact to the state of health of the patient involved.This report has been submitted with an abundance of caution.

• 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: 22792891
• Report Number: 3003202425-2025-00003
• Device Sequence Number: 8264475
• Product Code: JAK
• UDI-Device Identifier: 04056869151595
• UDI-Public: (01)04056869151595
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 08/13/2025

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: 07/15/2025
• Initial Report FDA Received Date: 08/13/2025
• 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
• Patient Sex: Unknown