Model Number SIPAP |
Device Problems
No Audible Alarm (1019); Device Operates Differently Than Expected (2913)
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Patient Problem
No Patient Involvement (2645)
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Event Date 09/01/2017 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).At this time, vyaire medical has not received the suspect device/component from the customer 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 that when the ventilator was turned on, the device had an e33 error code without an audible alarm.There was no patient involvement associated with this issue.
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Manufacturer Narrative
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Results of investigation: the vyaire failure analysis laboratory received the suspect component and performed a failure investigation.The reported issue was duplicated in the laboratory setting.The root cause of the reported issue revealed a defective transducer component, causing the e33 error.
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Event Description
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The customer reported that when the ventilator was turned on, the device had an e33 error code without an audible alarm.There was no patient involvement associated with this issue.
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Search Alerts/Recalls
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