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 11/27/2018 |
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 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 authorized distributor, reported that the freedom driver made a strange noise while supporting a patient.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 customer-reported issue, a strange sound coming from the driver, was reproduced during the extended observation run of the driver.The root cause was determined to be excessive wear of the piston cylinder assembly's (pca's) yoke dowel pin on the pca's cam follower.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 4591 follow-up report 1.
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Search Alerts/Recalls
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