Model Number 595000-001 |
Device Problem
Image Display Error/Artifact (1304)
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Patient Problem
No Patient Involvement (2645)
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Event Date 09/12/2019 |
Event Type
malfunction
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Manufacturer Narrative
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This alleged failure mode poses low risk to a patient because the issue was observed when the freedom driver was not supporting a patient.The freedom driver has been returned to syncardia for evaluation.The results of the investigation will be provided in a follow-up mdr.(b)(4).
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Event Description
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The freedom driver was not supporting a patient.The customer, a syncardia authorized distributor, reported that the patient's backup freedom driver display showed asterisks instead of numbers for the fill volume and cardiac output.
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Manufacturer Narrative
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During investigational testing, the customer-reported issue of the driver display showing asterisks instead of numbers for the cardiac output and fill volume was confirmed and reproduced.The root cause was determined to be a malfunction of the airflow sensor which was found to have internal wire corrosion.This issue will continue to be monitored and trended as part of the customer experience process.Syncardia has completed its evaluation of this complaint and is closing this file.Ce 4965 follow-up report 1.
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Search Alerts/Recalls
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