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

Model Number	10742326
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/13/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Siemens is conducting a thorough investigation of the reported event to identify the root cause of the issue.A supplemental report will be provided upon investigation completion.
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, the customer reported a loud noise and observed that the ct gantry shifted it¿s original position.As a result, a patient was injured.Further information regarding the patient's health status and the extent of injury is not known at this time.Siemens has requested additional information to conduct an investigation of the reported event.Therefore, this report is submitted with an abundance of caution.
Additional Manufacturer Narrative
Siemens has completed an investigation of the event.A patient hit her knee against the gantry.No abrasion occurred and an x-ray of the knee confirmed no further injury.The reported problem was resolved by replacing the gantry.This brought the system back to clinical operation.Our experts investigated the exchanged gantry and found an increased amount of foreign particles (e.G., calcium chloride, calcium carbonate, chlorine) inside the bearing.These particles can enter the bearing through water.Furthermore, the wear of the cage and balls was greatly increased.Such increased wear can lead to cage fractures.The individual cage segments and isolated balls can slide open and cause a ball jam.This can lead to the breaking of cage segments and finally result in a sudden stop.It should be mentioned that under-greasing increases the wear of individual components.Based on the investigation, it is obvious that the sudden stop happened right after fresh fat has entered the system.This increased the forces on the individual components (increased rotational resistance) and accelerated total failure.For somatom force systems which have an active siemens healthineers service contract the bearing is lubricated at least once a year.The customer has had no service contract with siemens healthineers after the warranty for the system ended on 2019-03-19.Accordingly, we cannot say if and how lubrication of the bearing took place in the last couple of years.We are not aware of any similar incidents.No systematic issue nor a general design issue was identified.

• Brand Name: SOMATOM FORCE
• Common Device Name: SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; 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: 18766667
• Report Number: 3004977335-2024-00022
• Device Sequence Number: 4462089
• Product Code: JAK
• UDI-Device Identifier: 04056869006956
• UDI-Public: 04056869006956
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/02/2025

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
• Device Catalogue Number: 10742326
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/13/2024
• Supplement Date Received by Manufacturer: 04/02/2025
• Initial Report FDA Received Date: 02/23/2024
• Supplement Report FDA Received Date: 04/02/2025
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown