Catalog Number 295050-001 |
Device Problem
Electrical /Electronic Property Problem (1198)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 01/09/2019 |
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 this issue did not prevent the freedom driver from performing its life-sustaining functions.In addition, the freedom driver has a redundant power source of onboard batteries.The freedom ac power supply has been 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 freedom home ac power supply is a component that enables the freedom driver to be plugged into an external power source.The customer, a syncardia certified hospital, reported that the freedom ac power supply indicator light is not lighting up and will not charge the onboard batteries.There was no reported adverse patient impact.
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Manufacturer Narrative
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The customer-reported issue of the freedom ac power supply not able to charge freedom onboard batteries was confirmed during the functional evaluation; the ac power supply could not provide enough output to charge onboard batteries installed in a driver.The root cause of the reported issue cannot be determined without physical access to the internal printed circuit board.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 4632 follow-up report 1.
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Search Alerts/Recalls
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