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

Model Number	10430603
Medical Device Problem Code	Unexpected Shutdown (4019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/28/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Siemens has completed an investigation of the event.The root cause was determined as a service issue.The reported problem was resolved by recalibrating the patient handling system (phs) and exchanging the tabletop position sensor.This brought the system back to clinical operation.The material consumption of the sensor in relation to the installed base is monitored by the capa process and is rated as acceptable.No systematic issue nor a general design issue was identified.Therefore, 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 definition flash ct system.The user reported a problem with the ct-scan of two patients.The first patient, a 72-year-old man, 100 kg, was examined on suspicion of an aortic dissection.The scan aborted twice and was successfully completed on the third try.The delay in diagnosis was approximately 26 minutes.Beside the additional radiation dose, no negative health consequences for the patient have been reported because of this delay.The second patient, a 34-year-old woman, 110 kg, was examined because of a suspected stroke.The scan aborted and the customer finished the diagnosis on an mri-system.According to the customer, the delay in diagnosis was 30 minutes.No negative health consequences were reported for the patient caused by this delay.

• Brand Name: SOMATOM DEFINITION FLASH
• 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: 21717553
• Report Number: 3004977335-2025-00047
• Device Sequence Number: 19997596
• Product Code: JAK
• UDI-Device Identifier: 04056869006963
• UDI-Public: (01)04056869006963
• 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: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/28/2025

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: 10430603
• 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: 02/28/2025
• Initial Report FDA Received Date: 03/28/2025
• 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: 72 YR
• Patient Sex: Male
• Patient Weight: 100 KG