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 09/18/2020 |
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 a fault alarm while supporting a patient.There was no reported adverse patient impact.The customer also reported that the patient was subsequently switched to a backup freedom driver.
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Manufacturer Narrative
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The driver's alarm history was reviewed and revealed a "2d" alarm code which can be produced during the extraction of the alarm history or engagement of the secondary motor.Visual inspection did not reveal any indication of secondary motor engagement.The driver passed all sections of functional testing including a 48-hour observation run with no alarms or abnormalities.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 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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