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 Code	Abrasion (1689)
Date of Event	08/17/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Siemens has completed an investigation of the event.The root cause was determined to be an operator error.The customer could not provide information regarding the circumstances or timing of the cover damage.Furthermore, the customer did not immediately replace the missing cover and continued to operate the system despite its absence.According to the definition as | instructions for use, print no.C2-029.620.16.03.02, page 33, chapter 2.1.2 ¿ general safety information ¿ general practice: damage or defects which occur to the system (patient table, gantry), to add-ons or accessories can result in an unsafe operation.Watch out for such damage and have these parts repaired or replaced immediately.A new cover has been installed by a siemens service engineer, and the system is operating accordingly.Based on the available investigation results which indicate neither a systematic nor design issue, this report is filed with an abundance of caution.The system works as specified and no further measures are deemed necessary.
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 patient of unknown sex and age sustained an injury to the arm due to a broken cover of the patient handling system (phs).According to the available information, during the table movement the bedsheet became entangled in the table, causing a superficial skin injury with minor bleeding, which stopped spontaneously.The wound was disinfected, and no further medical treatment was required.

• 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: 23062051
• Report Number: 3004977335-2025-00113
• Device Sequence Number: 21298662
• 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): 09/16/2025

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: 08/18/2025
• Initial Report FDA Received Date: 09/16/2025
• 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: Hospitalization
• Patient Sex: Unknown