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

Model Number	11061640
Medical Device Problem Code	Radiation Output Problem (4026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/11/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Siemens has completed an investigation of the event.A service engineer went onsite for a technical investigation.It was determined that the high voltage tank (hvt) was broken and needed to be replaced.After its replacement, the system was handed back to the customer in regular operation.No further investigation within the complaint process is necessary as no general or design issue was identified.No further measures are deemed necessary.The patient suffered no harm due to the delayed diagnosis, therefore the 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.Top ct system.A 79-year-old female patient was on the scanner for a contrast media guided stroke examination.The examination was not possible due to a technical issue and the patient was sent to another facility.A stroke was later excluded, and a uti infection was diagnosed.

• Brand Name: SOMATOM GO.TOP
• 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: 20852115
• Report Number: 3004977335-2024-00143
• Device Sequence Number: 8040066
• Product Code: JAK
• UDI-Device Identifier: 04056869151571
• UDI-Public: (01)04056869151571
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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: 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: 11061640
• 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: 11/11/2024
• 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: 79 YR
• Patient Sex: Female