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

Model Number	08098027
Medical Device Problem Codes	Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Limb Fracture (4518)
Date of Event	01/01/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to siemens that an adverse event occurred while operating the somatom definition as ct system.On (b)(6) 2025, a 77-year-old patient underwent an examination.During the unload, the patients¿ arm slipped down and was squeezed between the bed and the gantry resulting in a fracture of the right arm humerus.According to the available information, the patient was not fixed and not observed as recommended per the system operator manual.
Additional Manufacturer Narrative
Siemens healthineers is conducting a thorough investigation of the reported event.Should the investigation identify a general design, systematic issue, or any other reason as a root cause of this issue, a supplemental report will be filed.Based on the available information the system worked as specified.Additionally, warnings are provided in the system operator manual.According to the operator manual ¿ definition (order no.(b)(4)): movement of the tabletop entails a danger of injury.Unintentional patient movement! contusion of patient extremities at patient table and gantry.Always fix and observe the patient during system movements.

• Brand Name: SOMATOM DEFINITION AS
• 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: 21178119
• Report Number: 3004977335-2025-00011
• Device Sequence Number: 4300550
• Product Code: JAK
• UDI-Device Identifier: 04056869003665
• UDI-Public: (01)04056869003665
• 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): 01/17/2025

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: 08098027
• 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: 01/06/2025
• Initial Report FDA Received Date: 01/17/2025
• 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 Age: 77 YR
• Patient Sex: Unknown