Model Number SIPAP |
Device Problems
No Audible Alarm (1019); Device Operates Differently Than Expected (2913)
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Patient Problem
No Information (3190)
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Event Date 06/13/2017 |
Event Type
malfunction
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Manufacturer Narrative
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Vyaire medical complaint number (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 sipap unit was switched off, there was no audible alarm.The error log showed an e80 (audible alarm module not functioning) error code.It is unknown if there was patient involvement associated with this reported issue.
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Manufacturer Narrative
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The vyaire medical factory service received the suspect device, a sipap ventilator, and evaluated the device.An evaluation of the device duplicated the reported issue and isolated the issue to the main printed circuit board assembly (pcba).
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Search Alerts/Recalls
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