Model Number 595000-001 |
Device Problem
Noise, Audible (3273)
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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.(b)(4).
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Event Description
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The customer, a syncardia certified hospital, reported that the freedom driver exhibited an unusual noise 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 passed all sections of functional testing.Additionally, the driver underwent an extended observation run with no issues or unusual noise observed.During investigation testing, the customer-reported issue was not able to be reproduced and there was no evidence of a device malfunction.The root cause of the customer-reported unusual noise 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.(b)(4) follow-up report 1.
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Search Alerts/Recalls
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