Model Number 595000-001 |
Device Problem
Audible Prompt/Feedback Problem (4020)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/18/2020 |
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 of the investigation 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 a fault alarm while supporting a patient.There was no reported adverse patient impact.The customer also reported that the patient was switched to the backup freedom driver.
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Manufacturer Narrative
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The driver passed all sections of functional testing.Additionally, the driver also underwent an extended observation run and a battery exchange test with no issues or alarms 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 alarm 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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