MAUDE Adverse Event Report: SIEMENS HEALTHINEERS AG SOMATOM GO.UP; SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED

Model Number	11061620
Medical Device Problem Code	Radiation Output Problem (4026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/07/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Siemens has completed an investigation of the event.The technical investigation has identified that the system had an inconsistency in timing which caused the exception.Despite additional radiation dose for the repetition of the topogram scan, there was no other harm reported.The delay did not cause any other negative health consequences to the patient.This report is filed with an abundance of caution.
Event or Problem Description
It was reported to siemens that a malfunction occurred while operating the somatom go.Up ct system.The user reported that a scan of an 84-year-old female potential stroke patient was not possible after creating the topo.The preparation symbol (green circle) was spinning; but never changed.According to the user, this resulted in a 30-minute delay in diagnosis.

• Brand Name: SOMATOM GO.UP
• Common Device Name: SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
• Manufacturer (Section D): SIEMENS HEALTHINEERS AG; siemensstrasse 1 or; rittigfeld 1; forchheim 91301 ; GM 91301
• Manufacturer (Section G): SIEMENS HEALTHINEERS AG; siemensstrasse 1 or; rittigfeld 1; forchheim 91301 ; GM 91301
• Manufacturer Contact: meredith adams ; 40 liberty blvd.; malvern, PA 19355 ; 4843231631
• MDR Report Key: 20852121
• Report Number: 3004977335-2024-00144
• Device Sequence Number: 8100207
• Product Code: JAK
• UDI-Device Identifier: 04056869051314
• UDI-Public: (01)04056869051314
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K211373
• 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): 12/05/2024

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
• Operator of Device: Health Professional
• Device Model Number: 11061620
• 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: 11/07/2024
• Initial Report FDA Received Date: 12/05/2024
• 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
• Patient Age: 84 YR
• Patient Sex: Female