Model Number 595000-001 |
Device Problems
No Apparent Adverse Event (3189); Audible Prompt/Feedback Problem (4020)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/14/2020 |
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.(b)(4) initial.
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Event Description
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The customer, a syncardia authorized distributor, reported that the freedom driver exhibited intermittent fault alarms 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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The driver's alarm history was reviewed and revealed an alarm code which confirmed the customer-reported issue.The driver passed all steps of functional testing.Since the customer-reported fault alarm was not replicated during functional testing, a 48-hour observation run was performed.The driver did not exhibit any alarms.The root cause of the customer-reported fault alarm could not be conclusively determined.The driver performed as intended with no evidence of a device malfunction.This issue will continue to be tracked and trended as part of the customer complaint process.Syncardia has completed its investigation and is closing this file.(b)(4) follow-up report 1.
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Search Alerts/Recalls
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