VYAIRE MEDICAL, INC INFANT FLOW LP NASAL MASK - SMALL; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
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Model Number INFANT FLOW LP NASAL MASK SMALL |
Device Problem
Material Deformation (2976)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/09/2023 |
Event Type
Injury
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Manufacturer Narrative
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H3: 81 other - at this time, the suspect device has not been returned for evaluation.Therefore, root cause has not been determined yet.Vyaire medical asked the customer to hold onto items/packaging that are in question.This report is for the infant flow lp nasal mask small.Please see (b)(4) for infant flow lp nasal mask medium,(b)(4) for infant flow lp nasal prongs medium and (b)(4) for flow lp nasal prongs small.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.H3 other text : device not returned yet.
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Event Description
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It was reported to vyaire medical problem with infant flow lp nasal mask in which the mask and prong kinked, preventing the baby from breathing.Attempts were made by tightening or loosening sides, bigger and smaller masks, but did not help.Furthermore, there was not patient harm reported.The patient was taken off cpap (continuous positive airway pressure) and put on the heated mustache.
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