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Model Number 10590000 |
Device Problems
Incorrect, Inadequate or Imprecise Result or Readings (1535); Use of Device Problem (1670)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/23/2021 |
Event Type
malfunction
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Manufacturer Narrative
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The initial reporter's telephone number is: (b)(6).Siemens completed a technical investigation of the reported event.Based on the event log, an application error could not be detected during the workflow.The operator did not perform a topogram and then performed the spiral scan and repeated it twice (three scans in total).This event was determined to be a user error since no system error was found in the available log files and a topogram was not performed.A savelog was not created by the user, therefore, a more detailed investigation is not possible.No general design issue or product malfunction were identified based on the available data and information.
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Event Description
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It was reported to siemens that during a pelvimetry ct examination of a (b)(6)-year-old, pregnant woman using the somatom definition edge system, an issue occurred requiring the patient to be rescanned.The customized scan protocol did not include a topogram (low dose overview image) and following spiral scan was planned and executed without the assistance of the topogram.The primary function of a topogram is to be the planning base for the subsequent spiral scan.After the spiral scan was performed, the operator realized that the acquisition images did not contain the entire area of interest and the patient had to be rescanned.According to the patient protocol, the patient was scanned three times with a dose-length product (dlp) of 21mgy-cm for each scan range, resulting in a total dlp of 63mgy-cm.There has been no report of patient or fetal injury as of the date of this report.This report has been submitted with an abundance of caution.The reported event occurred in (b)(6).
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Search Alerts/Recalls
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