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

Model Number	10431700
Medical Device Problem Codes	Arcing (2583); Radiation Overexposure (3017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/23/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Siemens has completed an investigation of the reported event.The reported problem was resolved by replacing the x-ray tube.A system checkup and test scans were successfully performed, and the system is working as expected.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.
Event or Problem Description
It was reported to siemens that a malfunction occurred while operating the somatom drive ct system.A technical failure occurred during a perfusion scan for a potential acute stroke patient.It was reported that the scan aborted twice due to tube arcing.The 61-year-old female patient had to be removed and rescanned/reinjected on another device, resulting in a 40-minute delay.No medical intervention was required and no negative health consequences for the patient are reported.

• 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: 23434636
• Report Number: 3004977335-2025-00126
• Device Sequence Number: 4695165
• Product Code: JAK
• UDI-Device Identifier: 04056869006970
• UDI-Public: (01)04056869006970
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 10/31/2025

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: 10/23/2025
• Initial Report FDA Received Date: 10/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: 61 YR
• Patient Sex: Female