Model Number FLOW-I C40 |
Device Problem
Use of Device Problem (1670)
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Patient Problem
Cardiac Arrest (1762)
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Event Date 11/13/2021 |
Event Type
Death
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Manufacturer Narrative
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At treatment start or during treatment the preset or changed gas and ventilation settings has to be accepted by the user before activated.The pressure support mode of ventilation should be regarded as a support mode where the patient is the main driver of the ventilation.Pressure support is a patient initiated breathing mode in which the system supports the patient with a set constant pressure.Pressure support backup ventilation is controlled by the backup respiration rate.If no breath is detected within the specified backup frequency, a pressure controlled breath is administered.The back-up respiration rate is always present to alter both during pressure support and when changing to that ventilation mode during treatment.
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Event Description
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It was reported that the patient, whom had multiple co-morbidities were scheduled for le amputation, had been induced, intubated and then connected to the anesthesia workstation (hereafter named system) and the treatment was started.It was unnoticed by the user that the system parameter settings had not been reset and was rather from the previous treatment.The ventilation mode was pressure support and the backup respiratory rate was set to 4 b/min.This low respiratory rate resulted in inadequate minute volume.The patient coded and later died on arrival to icu when care was withdrawn.Manufacturer's reference #: (b)(4).
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Event Description
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Manufacturer's reference number: (b)(4).
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Manufacturer Narrative
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The investigation into this case concluded that the reported event was not caused by any anesthesia system device malfunction but instead the fact that after the patient had been induced, paralyzed, intubated and the anesthesia device had been turned on, the personnel did not notice that the parameter settings suggested on the user interface, which were accepted by the user, were from the prior case: system default pressure support settings.The respiratory rate was therefore set to 4 breaths per minute instead of the desired/expected 8 breaths per minute and this resulted in an inadequate minute ventilation.
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Search Alerts/Recalls
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