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

Model Number	10430603
Medical Device Problem Codes	Output Problem (3005); Radiation Output Failure (4027)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/22/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to siemens that a malfunction occurred while operating the somatom definition flash ct scanner.The customer attempted to perform a head spiral ct scan on a patient with a suspected stroke.The scan was aborted three times, and the patient was subsequently scanned on a different ct system.No stroke was detected; however, it was reported that the repeated scan aborts resulted in a diagnostic delay of approximately 25 minutes.We are unaware of any impact to the state of health of the patient involved.
Additional Manufacturer Narrative
Siemens has completed an investigation of the event.The root cause was determined to be a hardware error.The reported issue was resolved by replacing the supporting roll assembly of the patient handling system (phs).A safety assessment has been performed, and no general product or design-related issue was identified.The consumption rate of this spare part, relative to the installed base, is monitored through our capa (corrective and preventive action) process and remains within acceptable thresholds.Therefore, no further investigation under the complaint handling process is deemed necessary.This incident is being reported out of an abundance of caution.

• 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: 22825690
• Report Number: 3004977335-2025-00100
• Device Sequence Number: 17284288
• 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: Other,Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/18/2025

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: 07/22/2025
• Initial Report FDA Received Date: 08/18/2025
• 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: 69 YR
• Patient Sex: Male