Catalog Number 595000-001 |
Device Problem
Noise, Audible (3273)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 12/01/2016 |
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 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 an unusual noise while supporting a patient.The customer also reported that the patient was switched to a back-up freedom driver without any adverse patient impact.
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Manufacturer Narrative
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The freedom driver was returned to syncardia for evaluation.The driver in "as received" condition passed all functional test requirements, which included co, rap, aop, pap and lap performance metrics associated with normotensive and hypertensive settings.No abnormal noises were heard; the customer-reported strange noise was not reproduced during functional testing.Further testing was conducted in attempt to reproduce the customer-reported event.The driver was tested for an additional 120 hours at normotensive settings and performed as intended with no anomalies, unintended alarms, or strange noises heard.The customer experience was not reproduced; therefore, the root cause of the customer-reported strange noise could not be determined.There was no evidence of a device malfunction and the driver performed as intended.This issue will continue to be monitored and trended as part of the customer experience process.Syncardia has completed its evaluation of this complaint and is closing the file.(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 unusual noise while supporting a patient.The customer also reported that the patient was switched to a back-up freedom driver without any adverse patient impact.
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Search Alerts/Recalls
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