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

Model Number	10430603
Medical Device Problem Code	Device Handling Problem (3265)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	04/17/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Siemens has completed the investigation of the reported event.Based on the investigation, the event was determined to be use-related.During the examination, the patient was not secured using the intended fixation means, which can increase the risk of unintentional patient movement and injury.According to the instruction for use ¿ somatom definition flash operator manual (print no.C2 030.620.10.02.02, chapter a.2 information about personal safety, page a.2 8), the following warning is provided: ¿system movement ¿ movement of the tabletop entails a danger of injury.-caution - unintentional patient movement! contusion of patient extremities at patient table and gantry.Always fix and observe the patient during system movements.¿ based on the investigation results, the assessment does not indicate a system failure or malfunction.No general design issue, systematic issue, or non-conformity with the intended performance of the system was identified.No further actions are required, as there is no negative awareness regarding the quality, safety, or performance of the ct system, which was found to be working as specified.
Event or Problem Description
It was reported to siemens that an adverse event occurred while operating the somatom definition flash ct system.During the examination, the patient pressed his knee against the plexiglass ring and came into contact with moving parts of the system.As a result, the patient sustained a minor superficial laceration to the knee.The injury did not involve deeper structures such as ligaments or bone.The patient received medical treatment at the hospital, where sutures were applied to close the wound.

• 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: 25014210
• Report Number: 3004977335-2026-00072
• Device Sequence Number: 9632038
• Product Code: JAK
• UDI-Device Identifier: 04056869006963
• UDI-Public: (01)04056869006963
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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): 04/28/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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: 04/17/2026
• Initial Report FDA Received Date: 04/28/2026
• 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
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Unknown