Catalog Number 8603800 |
Device Problems
Gas Output Problem (1266); Failure to Deliver (2338); Intermittent Communication Failure (4038)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/15/2022 |
Event Type
malfunction
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Event Description
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It was reported that during elective orthopaedic surgery, sudden failure of anaesthetic machine occured.Unable to oxygenate/ventilate/modify machine interface in any way therefore transferred immediately to anaesthetic room.Patient was stable throughout.
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Manufacturer Narrative
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The investigation was just startet.The result will be forwarded in a follow-up report.
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Event Description
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It was reported that during elective orthopaedic surgery, sudden failure of anaesthetic machine occured.Unable to oxygenate/ventilate/modify machine interface in any way therefore transferred immediately to anaesthetic room.Patient was stable throughout.
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Manufacturer Narrative
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The replaced pcb mobi was available for investigaiton.During functional tests a dräger, the reported problem could be reproduced.A failure of the coma (communication master) processor onboard this pcb was the root cause for the reported event.It was found that the coma-processor performed sporadic restarts.These restarts prevented from communication with the other components of the device and lfinally resulted in the reported error message "internal system fault! device cannot be used.Notify dräger service".All alarms, possible causes and remedies are described in the instructions for use.Replacement of the pvb mobi has fixed the problem.The number of similar cases is within the expected range of the respective risk assessment and thus accepted.
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Search Alerts/Recalls
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