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

Model Number	10431700
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/20/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Siemens has completed an investigation of the reported event.The reported issue was resolved through the replacement of two fuses, f361 and f363 (service case).In addition, charging resistors r1 and r2 were inspected and confirmed to be within the expected specification of 48 ohms.The slip ring and brush block were also examined, and no anomalies were detected.Following these corrective actions and a system restart, the unit successfully entered standby mode without generating any errors.Multiple subsequent check-ups and flash test scans were performed, all yielding no issues, confirming the system's restored functionality.A comprehensive safety assessment has been performed.No further investigation is deemed necessary.Based on the findings, no systematic product or design issue could be identified.This event is reported in the abundance of caution.
Event or Problem Description
It was reported to siemens that a malfunction occurred while operating the somatom drive ct system during a flash aorta dissection pre & post contrast scan.After completing the topogram, contrast injection, and pre-monitoring, the system failed to reach standby and did not trigger the scan.The patient, a 58-year-old male (110 kg), had to be removed and rescanned/reinjected on another device, resulting in a 15-minute delay.No medical intervention was required.

• Brand Name: SOMATOM DRIVE
• 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: 23466252
• Report Number: 3004977335-2025-00128
• Device Sequence Number: 8861445
• Product Code: JAK
• UDI-Device Identifier: 04056869006970
• UDI-Public: (01)04056869006970
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K230421
• 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): 11/04/2025

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: 10431700
• 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: 10/20/2025
• Initial Report FDA Received Date: 11/04/2025
• 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
• Patient Age: 58 YR
• Patient Sex: Male