Model Number WATER STERILE F/INHALATION 2000ML 6/CS |
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 07/06/2022 |
Event Type
malfunction
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Event Description
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The customer reported to vyaire medical that there was a rust-colored or dark-red substance attached to the to the humidification chamber's inner plastic and floating inside the water of the humidification chamber while on a patient.No harm is associated with the event.
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Manufacturer Narrative
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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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Manufacturer Narrative
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Device evaluation: g3, g6, h2, h3, h6 and h10.Result of investigation: the suspect device was not returned for evaluation.The reported lot number and retained samples were tested and no trace of contamination were detected.No samples were returned and was unable to further investigate the complaint.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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