Model Number LOW FLOW BLENDER |
Device Problem
Mechanical Problem (1384)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/17/2021 |
Event Type
malfunction
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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.However, the complaint will be treating as and out of box failure (obf) and will replace the blender.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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The customer reported to vyaire medical that the low flow microblender ventilator is reading high and out of specification at a dial setting of 21%.Furthermore, there was no patient associated with the reported event.
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Manufacturer Narrative
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The problem occurred during testing; the unit failed dealer pre-acceptance testing and was never put in clinical use.
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Manufacturer Narrative
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Results of investigation: vyaire medical was unable to confirm or duplicate the reported issue as no performance issues were found.The utt (unit under test) was visually inspected and there was no evidence of damage or misuse.Installed utt assembly onto blender station fixture fa-lab gage id: a07012 and applied wall air and oxygen, the fraction of inspired oxygen (fio2) was set to 21% after 20 minutes and the fio2 external reading using servomex analyzer gage id: e00940 read at 22.13 percent.The fio2 was set to 30 %, 60 %, and 90 %, allowing each setting to flow for at least 20 minutes.All readings passed at each check point within the test specification.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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