VYAIRE MEDICAL, INC 3100 HIGH FREQUENCY OSCILLATING VENTILATOR (HFOV); VENTILATOR, HIGH FREQUENCY
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Model Number 3100A MISC REPAIR ITEM |
Device Problem
Contamination /Decontamination Problem (2895)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/01/2023 |
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, no root cause could be determined.However, customer was informed that vyaire medical have observed this kind of crystallization with normal saline from suctioning a patient creating crystals in circuit.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 problem with 3100a circuit where white substance that they might think be from xopenex treatment.Furthermore, there was no patient harm reported.Patient was manually ventilated and the circuit was changed, tested, and placed back on the patient with no adverse observed to the patient.
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Search Alerts/Recalls
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