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 04/20/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Vyaire medical file identification: pc-(b)(4).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%.As of this time there is no information about patient involvement associated with this reported event.
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Manufacturer Narrative
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Device evaluation: result of investigation: the vyaire failure analysis lab found the right outlet port physically damaged with the chrome plating peeling away.The reported failure is traced to user.A replacement product was shipped to the customer.
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Search Alerts/Recalls
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