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Model Number PACKAGE ASSEMBLY,INFANT FLOW,LP |
Device Problem
Pressure Problem (3012)
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Patient Problem
Low Oxygen Saturation (2477)
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Event Date 07/11/2019 |
Event Type
Injury
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Manufacturer Narrative
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At this time, the suspect device has not been returned for evaluation.Investigation is still ongoing.Therefore, no root cause could be determine yet.Any additional information received from the customer will be included in a follow-up report.
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Event Description
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The customer reported that the infant flow with a set of continuous positive nasal pressure generator had pressure anomaly (positive expiratory pressure and inspiratory pressure) while in use on a patient that resulted in decreased oxygen saturation (sao2) in the neonate.At first, the operator changed the device with same lot number (lot: 0004076953), but no success.Then they changed the device again with a different lot number (lot: 0004045851) and no recurrence of the incident.
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Search Alerts/Recalls
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