VYAIRE MEDICAL, INC P/N 9320 LOW FLOW AIR/OXYGEN MICROBLENDER; MIXER, BREATHING GASES, ANESTHESIA INHALATION
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Model Number MICROBLENDER |
Device Problem
Device Operates Differently Than Expected (2913)
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Patient Problem
Low Oxygen Saturation (2477)
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Event Date 10/18/2017 |
Event Type
Injury
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Manufacturer Narrative
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At this time, vyaire has not received the suspect device from the customer for evaluation.Several attempts have been made to contact the customer for additional information and to evaluate the suspect device for the reported issue.At this time, the customer has not responded to any contact attempts and vyaire medical is unable to confirm the customer's reported device issue.
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Event Description
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The customer reported while using the low flow air/oxygen blender; the device was only administering twenty one percent and not an one hundred percent supply of oxygen.The customer reported an infant patient required administration of surfactant which requires the patient to be intubated.The customer reported that the low flow air/oxygen blender in the neonatal intensive care unit was being used for the intubation process in order to provide adequate supply of oxygen.The customer reported after successful intubation, the staff administered breaths however the infant's saturations did not rise.The customer reported attempts to change the mask, check connections and adjust the settings were performed, however did not resolved the issue.The customer reported with no clinical changes the infant was extubated, then re-intubated.The customer reported the heart rate dropped and chest compressions were administered.The customer reported the respiratory therapist arrived with a ventilator and the patient's oxygen saturation immediately rose.The customer suspects that the most likely cause of the reported event is the low flow air/oxygen blender.
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