Model Number FLOW-I C30 |
Device Problem
Unexpected Therapeutic Results (1631)
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Patient Problem
Awareness during Anaesthesia (1707)
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Event Date 10/11/2019 |
Event Type
Injury
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Event Description
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The anesthesia work station was connected to a patient and the treatment was running in automatic ventilation with automatic gas control (agc) selected.The anesthetic agent was delivered in the beginning of the treatment but after change from sevoflurane (vaporizer in slot 1) to desflurane (vaporizer in slot 2) the agent delivery stopped.This was detected after 41 minutes and the system was after that set to manual gas control with sevoflurane vaporizer in slot 1 selected and agent delivery started.The patient awareness level increased and this was indicated by blood pressure and increased respiratory rate.No reported psychological harm.The patient has been discharged.Manufacturer's reference #: (b)(4).
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Event Description
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Manufacturer's reference #: (b)(4).
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Manufacturer Narrative
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This foreign complaint was reported based on the available information at the time.The investigation has however determined that the cause of the event is related to a specific sw version.This sw version is not released and will not be released on the us market, therefore no units on the us market are affected.This complaint does therefore not meet the reporting criteria for mdr and should not have been reported.
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Search Alerts/Recalls
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