Model Number ROTAFLOW CONSOLE |
Device Problems
Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913); No Flow (2991); Noise, Audible (3273)
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Patient Problem
Low Oxygen Saturation (2477)
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Event Date 02/03/2018 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).A follow-up medwatch will be submitted when additional information becomes available.
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Event Description
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It was reported that the patient was on v/v using rotoflow on free mode.Tt was free mode and medical staff states this is the only mode they utilize.They rolled the patient and immediately triggered a pump stop with the message reading ¿error¿ accompanied with an audible alarm they could not silence.Pump at this time had zero rpms and they were unable to remedy the alarm and unable to resume flow.Had to initiate emergency vent settings and went immediately to the hand-crank.Patient's sa02 dropped to 50%.Within 5 min of the pump stop, therapy was re-initiated using a different console.As of this am, patient is stable on new machine and no further issues reported.Internal reference: (b)(4).
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Manufacturer Narrative
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The rotaflow unit was returned to the depot in (b)(6) for further investigation.The service technician could not duplicate customer complaint.According to the service report the unit operated for five days without issues.All operating modes and warm and cold starts were tested.The service technician inspected the pcb´s, cables and safety check as per the service manual and the rotaflow device passed all test.
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Event Description
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(b)(4).
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Search Alerts/Recalls
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