VYAIRE MEDICAL INC. BABY SAFE HYP INF,.5L,60CMH20,MANO,NRPR; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
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Model Number BABY SAFE HYP INF,.5L,60CMH20,MANO,NRPR |
Device Problem
Pressure Problem (3012)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/05/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Vyaire medical file identification: (b)(4).At this time, the suspect device has not been returned for evaluation.Therefore, root cause has not been determined yet.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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It was reported to vyaire medical that the baby safe hyp inf,.5l, 60cmh20, mano, nrpr does not provide accurate pressure.The pressure needed to be increased to maintain the flow to the bag.At this time, there is no information regarding patient involvement associated with the reported event.
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