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

Model Number	10430603
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/13/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Siemens has completed an investigation of the reported event.The root cause was determined to be use error.The investigation confirmed that the ct system operated as intended and according to design specifications.No device deficiency or unexpected system behavior was identified.The head arm support accessory involved in the incident showed no damage and continued to be used after the event.The damaged gantry window strip was replaced, and normal system function was confirmed.While the exact sequence of events leading to the displacement of the accessory could not be conclusively reconstructed, the fact that the accessory was not defective supports the conclusion that the incident is most consistent with a handling related scenario rather than a failure of the device or accessory.According to information obtained during the investigation, the patient was not restrained at the time of the incident.The instructions for use describe precautions for accessory handling during system movement, stating that accessories such as head holders or supports must be used in a manner that prevents contact with the gantry (instructions for use, somatom definition flash, page 37, print no.C2 030.620.15.03.02).Furthermore, the instructions for use emphasize that the patient must be secured and observed during system movements and state: ¿always fix and observe the patient during system movements.¿ (instructions for use, somatom definition flash, page 41, print no.C2 030.620.15.03.02).Based on the available information, the incident is considered use related.The ct system functioned as specified, and the damage resulted from an external mechanical influence.No further corrective or preventive actions for the device were required.
Event or Problem Description
It was reported to siemens that a malfunction occurred while operating the somatom definition flash ct system.An incident occurred during patient unloading while using an adaptable head arm support accessory.During table retraction and downward movement, the head arm support became displaced and came into contact with the gantry window strip, resulting in mechanical damage to the window strip.As a precautionary measure, the system was taken out of service.No injuries to the patient or personnel were reported.

• 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: 24815995
• Report Number: 3004977335-2026-00046
• Device Sequence Number: 6027211
• Product Code: JAK
• UDI-Device Identifier: 04056869006963
• UDI-Public: (01)04056869006963
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 04/08/2026

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: 03/25/2026
• Initial Report FDA Received Date: 04/08/2026
• 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 Sex: Unknown