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

Model Number	08098027
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/21/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to siemens that a malfunction occurred while operating the somatom definition as ct system.It was reported that, during an examination of an emergency patient, an external patient monitoring device (intellivue patient monitor mx100) fell from the patient handling system (phs) and struck the gantry sealing ring.As a result of the impact, the sealing ring was penetrated, and contact occurred between the monitoring device and the rotating portion of the gantry.The patient monitor was positioned on the patient handling system between the patient's legs without being secured by a retaining strap.We are unaware of any impact to the state of health of the patient involved.
Additional Manufacturer Narrative
Siemens has completed an investigation of the reported event.The root cause was determined to be use-related factors.No system malfunction was identified.The system operated in accordance with its specifications.The falling of the external object into the gantry is considered to be outside the control of the manufacturer.The impact damaged the plexiglas ring and components within the rotating part of the gantry.The customer elected not to pursue repair of the system and instead decided to replace the ct.The affected ct system was taken out of service.A safety assessment has been performed.

• 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: 25676823
• Report Number: 3004977335-2026-00117
• Device Sequence Number: 11942119
• Product Code: JAK
• UDI-Device Identifier: 04056869003665
• UDI-Public: (01)04056869003665
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/01/2026

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: 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: 06/21/2026
• Initial Report FDA Received Date: 07/01/2026
• 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