Catalog Number 295053-001 |
Device Problem
Material Integrity Problem (2978)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 09/10/2018 |
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 it does not prevent the freedom driver from performing its life-sustaining functions.The freedom car charger will be returned to syncardia for evaluation.The results of the evaluation will be provided in a follow-up mdr.(b)(4).
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Event Description
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The freedom car charger is component that enables the freedom driver to be plugged into a 12v vehicle power outlet.The customer, a syncardia certified hospital, reported that the patient's freedom car charger connector was damaged.
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Manufacturer Narrative
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Visual inspection of the freedom car charger confirmed the customer-reported issue of connector damage.Functional inspection revealed that the car charger could not pass any charge from the ac power supply to the white connector or provide a connection to the driver with mechanical integrity.While the root cause cannot be determined, this damage was likely the result of rough handling or improper use.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 4464 follow-up report 1.
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Search Alerts/Recalls
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