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 06/19/2020 |
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 long fault alarm that eventually resolved.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 customer-reported fault alarm was not able to be reproduced or confirmed during investigation testing.Only permanent alarms are recorded in the driver's alarm history, intermittent and/or recoverable alarms are not recorded.During investigation testing, the driver passed all sections of functional testing.Additionally, a 48-hour observation run was performed with no alarms.The driver performed as intended with 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.Ce 5308 follow-up report 1.
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Search Alerts/Recalls
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