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Model Number AVEA |
Device Problems
Occlusion Within Device (1423); Device Operates Differently Than Expected (2913)
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Patient Problem
No Patient Involvement (2645)
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Event Date 12/20/2017 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Any additional information received from the customer will be included in a follow-up report.The customer reported calibrating the transducers however, that did not resolve the reported event.The customer reported the suspect device component is available for analysis and a return good authorization (rga) has been issued.At this time, vyaire medical has not received the suspect device component for evaluation.In the event that the device is received for evaluation or additional information is received, a follow-up report will be submitted.
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Event Description
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The customer reported during pre-use on startup, this ventilator device displayed a circuit occlusion alarm.The customer reported that there was no patient involvement.
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Manufacturer Narrative
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Results of investigation: the vyaire failure analysis laboratory received the suspect flow control valve (fcv) for investigation.The physical inspection found no anomalies with the fcv.The investigation did not duplicate the customer event during the performance and manufacture testing, which the fcv passed.Therefore, a definite root cause can not be determined, since no fcv component failure was identified.Vyaire will track and trend this reported issue and internally investigate the situation.
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Search Alerts/Recalls
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