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

Model Number	10742326
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	12/24/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the customers statement, this event is rated as a handling related issue as the patient was not observed well enough.No general product or systematic design issue has been identified.Therefore, no further measures are deemed necessary.
Event or Problem Description
It was reported to siemens that an adverse event occurred while operating the somatom force ct system.On (b)(6) 2024, a 65-year-old female hemiplegic patient was planned for a ct lung scan.It is reported that the patient was already in poor condition and could not move well.After the scan, while moving the patient back into the wheelchair, the customer claims that the patient was not observed well enough and that patient's arm became stuck, resulting in a fracture to the right upper limb.The patient was sent to the orthopedic department for further treatment and was hospitalized.The current patient health status is reported as stable.

• Brand Name: SOMATOM FORCE
• 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: 21079136
• Report Number: 3004977335-2025-00004
• Device Sequence Number: 17834070
• Product Code: JAK
• UDI-Device Identifier: 04056869006956
• UDI-Public: (01)04056869006956
• 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): 01/06/2025

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: 10742326
• 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: 12/27/2024
• Initial Report FDA Received Date: 01/06/2025
• 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: Other; Hospitalization
• Patient Age: 65 YR
• Patient Sex: Female