Catalog Number 8607000 |
Device Problems
No Pressure (2994); Insufficient Information (3190)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 11/03/2019 |
Event Type
malfunction
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Manufacturer Narrative
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The investigation is still on-going.The results will be provided within a follow-up report.
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Event Description
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It was reported that during the operation, the ventilation failed.The device posted an alarm and switched to manual ventilation.No injury reported.
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Manufacturer Narrative
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Further information as e.G.Log file and service report were requested for investigation at manufacturing site.Unfortunately no additional information was received so that no investigation could be performed and that finally no root cause could be determined explaining the reported symptom.In general in case of a ventilator failure automatic ventilation is not possible anymore.The device will generate an audible alarm and a visible alarm message "ventilator fail" will be displayed.The user can switch to manual ventilation as described in the instructions for use.Monitoring is still functional.The fabius is equipped with an integrated pressure- and volume-monitoring.
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Event Description
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Please refer to the initial-report.
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Search Alerts/Recalls
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