Catalog Number 595000-001 |
Device Problem
Noise, Audible (3273)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 10/10/2016 |
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) initial.
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Event Description
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The customer 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 reported adverse impact.
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Manufacturer Narrative
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The freedom driver was returned to syncardia for evaluation.The driver passed all functional test requirements with no anomalies or alarms.In addition, the driver was subjected to a 48 hour observation run and was confirmed to perform as intended with no issues.No unusual noises were heard.The driver performed as intended, and there was 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 of this complaint and is closing this file.(b)(4).
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Event Description
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The customer 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 reported adverse impact.
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Search Alerts/Recalls
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