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Model Number 10431700 |
Device Problem
Application Program Freezes, Becomes Nonfunctional (4031)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/12/2021 |
Event Type
malfunction
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Manufacturer Narrative
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The initial reporter name was not provided to siemens as of the date of this report and have been requested by siemens.A siemens employee reported the complaint to siemens.Siemens has initiated a technical investigation of the reported event.A root cause has not been identified.A supplemental report will be submitted upon completion of the investigation.
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Event Description
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It was reported to siemens that during a dual energy ct contrast scan of a (b)(6) male patient using the somatom drive system, the runoff scan could not be loaded after monitoring and the examination was aborted.The scan had to be repeated using a different ct system and additional contrast media was administered.The second low dose overview scan (topogram) was completed successfully.The patient did not suffer any adverse health issues due to the delay in the examination, additional low dose x-ray exposure and additional contrast media.This report has been submitted with an abundance of caution.
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Manufacturer Narrative
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Siemens performed technical evaluation of the reported event and system.The issue was caused by the customized scan protocol "de_runoff", in dual energy spiral range "de runoff" with rottime 1.0s and coll.Slice 64x0.6.The range is based on siemens mode de_extrangio_bonerem_ir.Adult", which is designed with rottime 0.33s, coll.Slice 32x0.6.The scanner could not find the correct calibration table with the invalid parameter which resulted in the reported problem.This system behavior will be resolved in the next servicepack vb20a_sp5.A defect for follow-up in siemens change management has been opened.
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Search Alerts/Recalls
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