Model Number AIRLIFE¿ ADULT HEATED WIRE CIRCUIT KIT |
Device Problem
Connection Problem (2900)
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Patient Problem
Hypoxia (1918)
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Event Date 11/24/2020 |
Event Type
Injury
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Manufacturer Narrative
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The customer reported that the device is discarded since it was used on a covid patient.However, the customer sent a photo of the device for evaluation.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.
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Event Description
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The customer reported that the airlife¿ adult heated wire circuit kit experienced 2 chambers come apart on patients while delivering high flow oxygen.The reported issue occurred in 2 incidents.The customer confirmed that the patients became hypoxic.Patient was placed on a non-rebreather mask until the heater chamber could be replaced.
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Manufacturer Narrative
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Result of investigation: picture received for investigation.Can see a chamber where the metallic plate was came off from the plastic housing.Therefore the defect reported by the customer was confirmed.Root cause traced to material used in chamber does not meet manufacturers specifications.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.
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Search Alerts/Recalls
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