Model Number 595000-001 |
Device Problem
Image Display Error/Artifact (1304)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/03/2021 |
Event Type
malfunction
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Manufacturer Narrative
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The freedom driver will be returned to syncardia for evaluation.The results will be provided in a follow-up mdr.Ce (b)(4).
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Event Description
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The freedom driver was not supporting a patient.The customer, a syncardia certified hospital, 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 investigation testing, the customer-reported issue was unable to be confirmed or reproduced.The driver passes all sections of functional testing and there was no evidence of device malfunction.The root-cause of the customer-reported asterisks on the display could not be determined.This issue will be monitored and trended as part of the customer experience process.Syncardia has completed its investigation and is closing this file.Ce 5479 follow-up report 1.
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Search Alerts/Recalls
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