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

Model Number	11330002
Medical Device Problem Codes	Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	07/28/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to siemens that an adverse event occurred while operating the somatom x.Ceed ct system.The in-hospital patient was not able to straighten his knee so the operator positioned the patient with his right knee bent.Prior to the scan, the operator checked that the patient would fit in the scanner well with his knee bent.After the complication-free topogram, the operator started the examination scan.Once table movements began, the patient further bent his knee causing his right knee to come in contact with the plexi ring in the gantry and moving parts of the gantry touched the patient's knee.The exam was immediately stopped and the patient was removed from the scanner.The patient suffered a laceration to his right knee approximately 2-3 inches in length in a diagonal direction which required stitches.Following treatment, the patient was discharged from the hospital on the same day.We are unaware of any further impact to the state of health of the patient involved.
Additional Manufacturer Narrative
Siemens has completed an investigation of the event.Following our investigation this event is rated as an accident.The ct system worked as specified and the operator spent reasonable efforts to assure safe patient positioning.Unwanted movement of the patient could have been avoided following the owner's manual (instructions for use) where it is recommended to use positioning aids (such as straps or belts) when necessary and to observe the patient during all system movements and to press the stop key in urgent situations.Based on available information the system worked as specified.No further measures are deemed to be necessary.

• Brand Name: SOMATOM X.CEED
• 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 HEALTHCARE GMBH; siemensstrasse 1~or; rittigfeld 1; forchheim 91301 ; GM 91301
• Manufacturer Contact: meredith adams ; 40 liberty blvd.; malvern, PA 19355 ; 4843231631
• MDR Report Key: 17497599
• Report Number: 3004977335-2023-00083
• Device Sequence Number: 19468877
• Product Code: JAK
• UDI-Device Identifier: 04056869231051
• UDI-Public: 04056869231051
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K211373
• 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
• Type of Report: Initial
• Report Date (Section B): 08/10/2023

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: 11330002
• Device Catalogue Number: 11330002
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/28/2023
• Initial Report FDA Received Date: 08/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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 Sex: Male