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

Model Number 10430603

Device Problems Display or Visual Feedback Problem (1184); Image Display Error/Artifact (1304)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/25/2023

Event Type  Injury  

Event 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.

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
• Type of Device: 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
• MDR Text Key: 320766331
• Report Number: 3004977335-2023-00084
• Device Sequence Number: 1
• Product Code: JAK
• UDI-Device Identifier: 04056869006963
• UDI-Public: 04056869006963
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K230421
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 10430603
• Device Catalogue Number: 10430603
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/25/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 4 YR
• Patient Sex: Female