CAREFUSION, INC INFANT FLOW PLUS INFANT CPAP SYSTEM WITH SIPAP FUNCTION; VENTILATOR, NON-CONTINUOUS
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Model Number SIPAP |
Device Problem
Device Operates Differently Than Expected (2913)
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Patient Problem
No Patient Involvement (2645)
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Event Date 11/16/2016 |
Event Type
malfunction
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Manufacturer Narrative
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Carefusion complaint number (b)(4).(b)(4).At this time, carefusion has not received the suspect device/component from the customer for evaluation.At this time, the customer has not responded to requests for additional information regarding this event.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 unit was switched off, there was no audible alarm.As the customer reported that they were turning the unit off, there is no patient involvement nor adverse event.
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Manufacturer Narrative
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Results of investigation: the carefusion failure analysis laboratory 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 a super capacitor on the main printed circuit board assembly (pcba) not holding enough charge to activate the buzzer to create an audible tone.
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