NIHON KOHDEN ORANGEMED, INC. NIHON KOHDEN NKV-550 SERIES VENTILATOR SYSTEM; VENTILATOR, CONTINUOUS, FACILITY USE
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Model Number NKV-550-U |
Device Problem
Gas/Air Leak (2946)
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Patient Problem
Insufficient Information (4580)
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Event Date 03/04/2021 |
Event Type
malfunction
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Manufacturer Narrative
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At this time, the suspect device has not been returned for evaluation.Therefore, root cause has not been determined yet.A supplemental report will be issued if additional information is obtained.
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Event Description
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It was reported that there was an oxygen leakage from below the device during patient use.After patient was removed the ventilator, the user checked the service screen and the o2 inlet pressure reading was 20.0 psi.No other details have been provided even after multiple attempts by manufacturer.This mdr will be updated once more details are obtained.
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Manufacturer Narrative
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Evaluation complete.See attached evaluation summary report.
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Search Alerts/Recalls
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