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

Model Number	10430603
Medical Device Problem Codes	No Device Output (1435); Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/23/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cause of the issue is not known at this time.A system restart resolved the issue directly and it has not reoccurred.Logfiles were taken from the system for further analysis.Siemens will provide a supplemental report if any systematic or design issue is identified as the root cause for the problem.
Event or Problem Description
It was reported to siemens that a malfunction occurred while operating the somatom definition flash ct system.On (b)(6) 2023 a 7-month-old child (male, 9 kg) was scheduled for a heart scan to plan a surgery of the aortic arch.The scanner did not start after topo and 20 ml contrast media was injected.A second scan was made with an additional 8 ml of contrast media.According to the hospital, the second contrast media calculation was not exact, and the images could also not be used for diagnosis.The hospital confirmed that a third scan was conducted on (b)(6) 2023.The patient was transferred from a neighboring hospital and there is currently no information available regarding the health status of the patient.Siemens considers children as a vulnerable patient group; therefore, this report has been submitted with an abundance of caution.

• Brand Name: SOMATOM DEFINITION FLASH
• Common Device Name: SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH-CT; siemensstr. 1 -or-; rittigfeld 1; forchheim, germany 91301 ; GM 91301
• Manufacturer (Section G): SIEMENS HEALTHCARE GMBH-CT; siemensstr. 1 -or-; rittigfeld 1; forchheim, germany 91301 ; GM 91301
• Manufacturer Contact: meredith adams ; 40 liberty blvd.; malvern, PA 19355 ; 4843231631
• MDR Report Key: 16688678
• Report Number: 3004977335-2023-68470
• Device Sequence Number: 14972495
• Product Code: JAK
• UDI-Device Identifier: 04056869006963
• UDI-Public: 4056869006963
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K190578
• 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
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date (Section B): 04/06/2023

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: 10430603
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/24/2023
• Initial Report FDA Received Date: 04/06/2023
• 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
• Patient Sequence Number: 1
• Patient Age: 7 MO
• Patient Sex: Male
• Patient Weight: 9 KG