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

Model Number	11061640
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/12/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Siemens healthineers has requested additional information to conduct a thorough investigation of the reported event.Should the investigation identify a general design or systematic issue, or any other reason as a root cause of this issue, a supplemental report will be filed.
Event or Problem Description
It was reported to siemens that a malfunction occurred while operating the somatom go.Top ct system.On (b)(6) 2024, the customer started a stroke study of a 65-year-old female and completed the study.The reconstruction of the images took approximately 25 to 27 minutes resulting in a delay of the procedure.There is no report of impact to the state of health of the patient due to the delay, however, in a worst-case scenario the delay could have serious health consequences for a stroke patient.Siemens healthineers has requested additional information to conduct a thorough investigation of the reported event.This report is being submitted with an abundance of caution.

• Brand Name: SOMATOM GO.TOP
• Common Device Name: SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; siemensstrasse 1 ~or; rittigfeld 1; forchheim 91301 ; GM 91301
• Manufacturer (Section G): SIEMENS HEALTHCARE GMBH; siemensstrasse 1 ~or; rittigfeld 1; forchheim 91301 ; GM 91301
• Manufacturer Contact: meredith adams ; 40 liberty blvd., mc 65-1a; malvern, PA 19355 ; 4843231631
• MDR Report Key: 19094948
• Report Number: 3004977335-2024-00041
• Device Sequence Number: 7840277
• Product Code: JAK
• UDI-Device Identifier: 04056869151571
• UDI-Public: 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
• Type of Report: Initial
• Report Date (Section B): 04/12/2024

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
• Device Catalogue Number: 11061640
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/13/2024
• Initial Report FDA Received Date: 04/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: 65 YR
• Patient Sex: Female