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
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/09/2021 |
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.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 ventilator was connected to patient and started to have an oxygen leak from bottom of ventilator.The doctors changed to a backup ventilator.No patient harm is noted.Reporting hospital is not willing to provide any patient information.In the service screen, it shows the oxygen inlet pressure reading 24.4 psi.
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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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