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

Model Number	11061630
Medical Device Problem Code	Image Display Error/Artifact (1304)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/02/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter is a siemens employee.A contact name for the facility were not provided.Siemens completed a detailed technical investigation of the reported event.It was determined that the root cause of the issue is associated with the balancing algorithm of the used reconstruction algorithm (kernel).This algorithm is not optimized for the comparatively low hu (hounsfield units) values of the pediatric skull (soft bone structure at infants), leading to the observed artifact.The ct scanner is working as specified according to technical limits and the occurrence of the artifact is highly sporadic.An internal change request has been established to consider an improvement of the named issue for future service packs or software versions.According to the siemens medical expert, no immediate therapy is being medically indicated, based on this pathological finding only.The clinical symptoms of the patient will always be considered before starting a therapy.
Event or Problem Description
It was reported to siemens that during a ct scan of a (b)(6) child on (b)(6) 2022, the customer observed artifacts in the ct images of the brains.The artifacts appeared as hypodense areas in occipital region of the brain.The perceived artifacts meant that a subdural collection could not be excluded.Therefore, the customer decided to perform further diagnostic imaging using an mri scanner.The initial pathology could not be confirmed in the mri scans.There was no reported patient injury associated with the reported event.Additional information regarding the health status of the patient was not provided to siemens.Per the customer, this was the first time these kinds of artifacts were observed.Other pediatric patients had been scanned without artifacts.This report was submitted with an abundance of caution.The reported event occurred in the (b)(6).

• Brand Name: SOMATOM GO.ALL
• Common Device Name: SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; siemenstrasse 1; forchheim, 91301 ; GM 91301
• Manufacturer (Section G): SIEMENS HEALTHCARE GMBH; siemenstrasse 1; forchheim, 91301 ; GM 91301
• Manufacturer Contact: rebecca tudor ; 40 liberty blvd.; 65-1a; malvern, PA 19355 ; 4843234198
• MDR Report Key: 13721840
• Report Number: 3004977335-2022-16977
• Device Sequence Number: 17344991
• Product Code: JAK
• UDI-Device Identifier: 04056869151564
• UDI-Public: 04056869151564
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K211373
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/09/2022

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: 11061630
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/14/2022
• Initial Report FDA Received Date: 03/10/2022
• 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: Reuse
• Patient Sequence Number: 1
• Patient Age: 3 MO
• Patient Sex: Unknown