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 02/27/2019 |
Event Type
malfunction
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Manufacturer Narrative
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This alleged failure mode poses a 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 reported that freedom driver display showed asterisks and not numbers for the fill volume and cardiac output.
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Manufacturer Narrative
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The driver successfully passed all functional test requirements.The customer-reported display with asterisks could not be confirmed or reproduced during investigation testing; therefore, the root cause of the customer-reported issue could not be determined.The driver performed as intended with no evidence of a device malfunction.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 4691 follow-up report 1.
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Search Alerts/Recalls
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