Device Problems
False Negative Result (1225); Incorrect Measurement (1383); Incorrect, Inadequate or Imprecise Result or Readings (1535); Output Problem (3005)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 10/23/2020 |
Event Type
Injury
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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 the etco2 readings went down during a surgery which was confirmed by blood gas analysis.Medication was applied to stabilize the patient and, the surgery was aborted.
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Manufacturer Narrative
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The invesigation was performed based on the reported information.The users described that they found out that the water trap had not been adjusted properly.It had not snapped in on both sides.Such improper assembly may cause a leak between water trap and water trap adapter.Due to such leak the sampled gas may be dilluted with ambient air.This explains the observed drop in measured etco2.The investigation has not revealed any device failure.Incomplete assembly of the water trap was the root cause of the reported event.The water traps come with a description of the correct assembly.Given that, this case can be considered a use error.In case the sampled gas is dilluted with ambien air, the readings for all gases will deviate from the actual conditions at the y-piece, where the gas is sampled from.The gas readings are permanently displayed on the primus screen.Depending on the alarm limits adjusted by the user, corresponding alarms may be generated.
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Event Description
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It was reported that the etco2 readings went down during a surgery which was confirmed by blood gas analysis.Medication was applied to stabilize the patient and, the surgery was aborted.
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Search Alerts/Recalls
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