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

Model Number 11061630

Device Problem Image Display Error/Artifact (1304)

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

Event Date 02/02/2022

Event Type  malfunction  

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 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
• Type of Device: 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
• MDR Text Key: 287341617
• Report Number: 3004977335-2022-16977
• Device Sequence Number: 1
• Product Code: JAK
• UDI-Device Identifier: 04056869151564
• UDI-Public: 04056869151564
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K211373
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 11061630
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 3 MO