Model Number 595000-001 |
Device Problems
Device Displays Incorrect Message (2591); Audible Prompt/Feedback Problem (4020)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
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Event Date 02/17/2018 |
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, the freedom driver 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 subsequently switched to the backup freedom driver.There was no 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.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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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.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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