Model Number 595000-001 |
Device Problem
Audible Prompt/Feedback Problem (4020)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 11/28/2018 |
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 the reported issue did not prevent the freedom driver from performing its life sustaining function.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 a fault alarm while supporting a patient while he slept at night.The customer also reported that the patient was switched to a backup driver without any adverse patient impact.
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Manufacturer Narrative
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The driver in "as received" condition passed all sections of functional testing.Additionally, an extended observation run was performed and the driver performed as intended with no alarms or abnormalities.The customer-reported issue was not reproduced during the investigation testing and there was no evidence of a device malfunction.The root cause of the customer-reported alarm could not be conclusively determined.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.Ce 4590 follow-up report 1.
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Search Alerts/Recalls
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