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

Model Number	10430603
Medical Device Problem Codes	Display or Visual Feedback Problem (1184); Image Display Error/Artifact (1304)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/25/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to siemens that an adverse event occurred while operating the somatom definition flash ct system.During a scan of a 4-year-old female patient, the operator reported artifacts on the head images.As a result, the clinical staff made the decision to conduct a rescan of the patient.No negative health consequences were reported for the child associated with the reported event.Therefore, this report is submitted with an abundance of caution as siemens considers children as a vulnerable patient group.
Additional Manufacturer Narrative
Siemens has completed an evaluation of the event.The child was rescanned due to image artifacts (windmill artifacts) during a head scan.Such artifacts point to a mismatch between the table movement speed and the scanner rotation speed.The customer adjusted the pitch parameter and rescanned the patient and artifacts no longer appeared.Based on available information the system worked as specified.No further measures are deemed to be necessary.

• Brand Name: SOMATOM DEFINITION FLASH
• 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: 17497603
• Report Number: 3004977335-2023-00084
• Device Sequence Number: 16780162
• Product Code: JAK
• UDI-Device Identifier: 04056869006963
• UDI-Public: 04056869006963
• 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: Foreign,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: 10430603
• Device Catalogue Number: 10430603
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/25/2023
• Initial Report FDA Received Date: 08/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Usage of Device: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 4 YR
• Patient Sex: Female