Device Problem
Disconnection (1171)
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Patient Problem
No Patient Involvement (2645)
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Event Date 09/04/2017 |
Event Type
malfunction
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Manufacturer Narrative
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Replaced gas o2 gas control module; n2o gas control module; and air gas control module to fix the reported issue.No report of patient involvement.(b)(4).
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Event Description
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The hospital reported that, during pre-use checkout, unit showed n2o hardware mixer failure.N2o gas hose disconnected from the pipe line.There was no reported patient involvement.
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Manufacturer Narrative
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The mdr follow-up #1 was submitted with the incorrect manufacturer report number 9710602-2017-00311.This mdr follow-up #2 is being submitted with the correct number 9710602-2017-00239.The mdr follow-up #1 was submitted with the incorrect manufacturer report number 9710602-2017-00311.This mdr follow-up #2 is being submitted with the correct number 9710602-2017-00239.
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Search Alerts/Recalls
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