Model Number 595000-001 |
Device Problems
Device Displays Incorrect Message (2591); No Apparent Adverse Event (3189)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 06/08/2018 |
Event Type
malfunction
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Manufacturer Narrative
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This alleged failure mode poses a low risk to the patient because although the freedom driver exhibited a fault alarm, it continued to perform its life-sustaining functions.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.The customer also reported that the patient was switched to a back-up freedom driver without any reported adverse patient impact.
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Manufacturer Narrative
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The driver in "as received" condition passed all test sections and pressure performance metrics associated with normotensive and hypertensive settings.Additionally, during an extended observation run test, the driver performed as intended and cardiac output remained within specifications.The customer-reported issue of a fault alarm could not be reproduced during investigation testing.The root cause of the customer-reported issue cannot be conclusively determined as the driver performed as intended with no evidence of a device malfunction.This issue will continue to be monitored and trended as part of the customer experience process.Syncardia has completed its evaluation and is closing this file.(b)(4) follow-up report 1.
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Search Alerts/Recalls
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