Model Number 595000-001 |
Device Problems
No Apparent Adverse Event (3189); Noise, Audible (3273)
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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 01/26/2018 |
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 an unusual noise, it continued to provide its life-sustaining functions.The freedom driver has been 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 an unusal sound while supporting a patient.The customer also reported that the patient was subsequently switched to a 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.Additionally, during an extended observation run test, the driver performed as intended with no unusual noise.The customer-reported driver noise 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).
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Search Alerts/Recalls
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