Catalog Number 295600-001 |
Device Problem
Break (1069)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 05/13/2019 |
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 the reported issue did not prevent the freedom driver from performing its life sustaining functions.In addition, the freedom driver has a redundant power source of multiple onboard batteries.The freedom home ac power supply 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 freedom 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 a piece of the connector on the patient's freedom home ac power supply was broken.
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Manufacturer Narrative
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Visual inspection of the power supply confirmed the customer-reported issue of a broken white hypertronics connector.Investigational testing could not be performed on the power supply due to the damaged connector.The root cause of this damage could not be determined, but it is most likely due to rough handling.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.Ce 4803 follow-up report 1.
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Search Alerts/Recalls
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