Catalog Number 8606500 |
Device Problem
No Pressure (2994)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 10/23/2019 |
Event Type
malfunction
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Manufacturer Narrative
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The investigation has just started; results will be provided in a follow up-report.
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Event Description
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It was reported that there was a ventilator fail during use.There was no injury reported.
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Manufacturer Narrative
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The investigation was performed based on the given information including the electronic log file.The case in question could be reconstructed by means of the information stored therein.On 15:24 on the reported date of event the device detected an encoder check error.This indicates a problem with the position detection of the ventilator piston.A failure of the motor or the light barrier cable of the ventilator assembly is considered the most likely root cause.The apollo reacted as specified as it shut down automatic ventilation and posted a corresponding visible and audible ventilator fail alarm.In such case manual ventilation and monitoring remain available to continue the case.The number of similar cases is within the expected range of the respective risk assessment and thus accepted.
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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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