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 06/29/2020 |
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 the 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 passed all sections of functional testing.Additionally, the driver underwent an extended observation run with no issues or alarms observed.The driver's alarm history was reviewed and no new alarms were recorded.Only permanent alarms are recorded in the driver's alarm history, intermittent and/or recoverable alarm are not recorded.During investigation testing, the customer-reported issue was not able to be confirmed or reproduced.The root cause of the customer-reported alarm could not be determined.The driver performed as intended with no evidence of a device malfunction.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 5310 follow-up report 1.
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Search Alerts/Recalls
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