Model Number 595000-001 |
Device Problem
Audible Prompt/Feedback Problem (4020)
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Patient Problems
High Blood Pressure/ Hypertension (1908); No Consequences Or Impact To Patient (2199)
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Event Date 08/21/2018 |
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 although the freedom driver exhibited a fault alarm, 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.
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Event Description
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The customer, a syncardia authorized distributor, reported that the freedom driver exhibited a fault alarm.The customer also reported that the patient was hypertensive.The patient was subsequently switched to a backup freedom driver without any adverse patient impact.
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Manufacturer Narrative
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Visual inspection identified a broken external connector on the connection 1 receptacle cable.The root cause of the damaged external connector cannot be conclusively determined, but is likely the result of excessive extraction force being applied with disconnecting the power adaptor from the driver, or as a result of rough handling/impact shock.The driver's alarm history was reviewed and revealed a '34' fault code alarm which could have been the customer-reported alarm.This type of alarm is usually produced because of intermittent power communication errors and it correlates with the broken external connector of connection 1 receptacle cable.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.(b)(4) follow-up report 1.
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Search Alerts/Recalls
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