Model Number 595000-001 |
Device Problems
Display or Visual Feedback Problem (1184); Image Display Error/Artifact (1304)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/10/2020 |
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); initial.
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Event Description
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The customer, a syncardia certified hospital, reported that the freedom driver display showed asterisks instead of numbers for the fill volume and cardiac output while supporting the patient.There was no reported adverse patient impact.The customer also reported that the patient was subsequently changed to a backup driver.
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Manufacturer Narrative
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Visual inspection of the driver revealed cracks in the display cover.The driver passed all sections of functional testing.During investigation testing, the customer-reported issue was not reproduced and there was no evidence of a device malfunction.The root cause of the customer-reported issue could not be conclusively determined.It is possible that an impact shock to the driver, as evidenced by the cracks in the display cover, could have temporarily dislodging the freedom onboard battery and caused an intermittent power connection resulting in the screen showing *** for the fill volume and cardiac output estimation.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 5414 follow-up report 1.
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Search Alerts/Recalls
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