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

Model Number	11061628
Medical Device Problem Codes	Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	09/19/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Siemens is conducting a thorough investigation of the reported events.As this event is under investigation, a root cause has not yet been determined.A supplement report will be filed upon completion of the investigation.
Event or Problem Description
It was reported to siemens that an adverse event occurred while operating the somatom go.Up ct system.During a topo scan, it was reported that the patient's arm pierced the plexi ring and extended into the gantry.The patients arm came into contact with rotating parts in the gantry, resulting in a fracture to the left arm.The patient was evaluated by medical staff and will receive further treatment at a later time.Siemens has requested additional information in order to conduct an investigation of the reported event.
Additional Manufacturer Narrative
Siemens has completed an investigation of the reported event.The root cause was determined to be an operator error.It was reported to siemens that an adverse event occurred while operating the somatom go.Up ct system.During a topo scan, it was reported that the patient's arm pierced the plexi ring and extended into the gantry.The patients arm encountered rotating parts in the gantry, resulting in a fracture to the left arm.A simulation of the reported event was performed based on logfile analysis.Based on the technical investigation, it was determined that the patient did not lie flat on the table and the restraint strap was not used correctly.The operator manual, c2-081b-c.621.06, clearly indicates 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.No further actions are to be taken as there is no negative awareness regarding the quality and performance of the system.No systematic problem was identified, and the ct system works as specified.
Additional Manufacturer Narrative
Siemens has become aware of new patient information received on (b)(6), 2023.It was reported to siemens that the patient subsequenlty passed away on an unknown date and time.There is no causal relationship between the patients death and the operation of the ct system.Following evaluation, siemens has determined that the root cause of the reported issue remains an operator error.During a topo scan, it was reported that the patient's arm pierced the plexi ring and extended into the gantry.The patients arm encountered rotating parts in the gantry, resulting in a fracture to the left arm.A simulation of the reported event was performed based on logfile analysis.Based on the technical investigation, it was determined that the patient did not lie flat on the table and the restraint strap was not used correctly.The operator manual, c2-081b-c.621.06, clearly indicates 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.No further actions are to be taken as there is no negative awareness regarding the quality and performance of the system.No systematic problem was identified, and the ct system works as specified.

• Brand Name: SOMATOM GO.UP (CN)
• Common Device Name: 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: 15500555
• Report Number: 3003202425-2022-45320
• Device Sequence Number: 11242689
• Product Code: JAK
• UDI-Device Identifier: 04056869051321
• UDI-Public: 04056869051321
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K200524
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Remedial Action: Inspection
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/08/2023

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: 11061628
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/19/2022
• Supplement Date Received by Manufacturer: 11/15/2022; 02/06/2023
• Initial Report FDA Received Date: 09/28/2022
• Supplement Report FDA Received Date: 11/15/2022; 02/08/2023
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Female