Model 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 12/12/2016 |
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 a 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 a noise while supporting a patient.The customer also reported that the patient was switched to a back-up freedom driver without any reported adverse patient impact.
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Manufacturer Narrative
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The freedom driver was returned to syncardia for evaluation.The customer-reported noise was not confirmed or reproduced during this investigation.The driver passed all test sections and pressure performance metrics associated with normotensive and hypertensive settings.Additionally, an extended observation run was performed, during which the driver functioned as intended with no anomalies, unintended alarms or noises.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) follow-up report 1.
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Event Description
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The customer, a syncardia authorized distributor, reported that the freedom driver exhibited a noise while supporting a patient.The customer also reported that the patient was switched to a back-up freedom driver without any reported adverse patient impact.
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Search Alerts/Recalls
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