VYAIRE MEDICAL INC AVEA II,CMPRH,BSC LNG,LO V,DISS K; VENTILATOR, CONTINUOUS, FACILITY USE
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Model Number AVEA II,CMPRH,BSC LNG,LO V,DISS K |
Device Problem
No Display/Image (1183)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/13/2024 |
Event Type
malfunction
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Manufacturer Narrative
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Vyaire medical file identification: (b)(4).H3: other - at this time, the suspect device has not been returned for evaluation.Therefore, root cause has not been determined.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 avea vent's screen is blank upon startup.No patient involvement was reported.
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Search Alerts/Recalls
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