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Catalog Number 768901 |
Device Problem
No Device Output (1435)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/26/2024 |
Event Type
malfunction
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Manufacturer Narrative
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Vyaire medical file identification: (b)(4).H3: 81 other - 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.H3 other text : not returned.
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Event Description
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It was reported to vyaire medical that the unit "froze" while it was running during the pre-use testing, no patient involvement.It seemed to freeze then started up again.
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Search Alerts/Recalls
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