Model Number 3100 B |
Device Problem
Mechanical Problem (1384)
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Patient Problem
No Patient Involvement (2645)
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Event Date 08/24/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Vyaire file identification: (b)(4).Any additional information received from the customer will be included in a follow-up report.At this time, the suspect device has not been return for investigation.Therefore, no further evaluation can be identified.
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Event Description
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The customer reported that a 3100b ventilator experienced unstable power noisey driver.The customer confirmed that there was no patient involvement.The reported issue occurred during set-up prior to patient use.
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Manufacturer Narrative
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Result of investigation: a vyaire field service representative (fsr) went onsite and evaluated the ventilator.Fsr replaced bad drive.Checked power supply, calibrated pressure transducer and completed pneumatics checkout.Rffun alarm checks, calibrated ddi board and driver controller.A test was conducted and the device was running well as it should according to specification.
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Search Alerts/Recalls
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