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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 Consequences Or Impact To Patient (2199)
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Event Date 03/16/2018 |
Event Type
Injury
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Manufacturer Narrative
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The customer reported the suspect gas delivery engine (gde) component is available for analysis and a return good authorization (rga) has been issued.At this time, vyaire medical has not received the suspect gde 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 an intermittent "circuit occlusion" alarm and the tidal volume out of specifications while in use on this ventilator device.The patient was removed and placed on an alternate ventilator device.The customer stated that there was no patient harm or injury associated with this event.The hospital biomed reported evaluating the ventilator device, which found the peep setting out specifications and the device autocycling.The biomed calibrated the transducers, which seemed to resolve the issue however, the transducers fell out tolerance intermittently.
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Search Alerts/Recalls
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