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Catalog Number 768901 |
Device Problem
Unexpected Shutdown (4019)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/25/2024 |
Event Type
Injury
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Event Description
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It was reported to vyaire medical that this unit powered off while on a patient.No harm reported.
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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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Search Alerts/Recalls
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