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Lot Number 600001 |
Device Problem
Labelling, Instructions for Use or Training Problem (1318)
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Patient Problem
No Patient Involvement (2645)
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Event Type
malfunction
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Manufacturer Narrative
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The instructions for use (ifu) do not contain a warning that contraindicates imaging with unity in pregnancy.A possible scenario is that due to this warning not being present, the user is unaware of this contraindication and the user allows a pregnant patient to be imaged on the mr linac.The hazardous scenario is that the user incorrectly enters the patient as mr eligible when they are not (due to pregnancy).Note, in current mr radiology practice, users are able to make changes to the available sequences to limit the sar and rf exposure to the foetus.This is not possible on the unity system.The hazardous situation in this case is that the foetus is exposed to excessive rf energy whilst being imaged using the mr linac.The severity of the harm is considered serious.The severity has been assessed as serious and the probability of occurrence of harm is implausible.The risk level has been assessed to be low.
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Event Description
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No adverse event has occurred.Warnings regarding pregnancy and the mri imaging using the mr linac are not contained within the instructions for use.Under normal mr operating conditions (radiology use), pregnancy requires the mr user to make changes to available sequences in order to limit the specific absorption rate (sar) and radio frequency (rf) effects to the foetus.However, for unity access to and adjustment of these parameters is not available.Pregnant women are therefore contraindicated for imaging using the mr linac.The instructions for use do not contain a warning regarding contraindication for imaging in pregnancy.However, the system does have a rcm implemented in the form of a mr daily assessment checklist that contains a question on whether the patient is pregnant or not.If this answer to this question if "yes" - imaging would not start.
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Search Alerts/Recalls
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