Catalog Number 295053-001 |
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 12/30/2019 |
Event Type
malfunction
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Manufacturer Narrative
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The freedom car charger 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 car charger is a 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 did not work.There was no reported adverse patient impact.
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Manufacturer Narrative
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During the investigation, the car charger was confirmed to be nonfunctioning.The car charger's output voltage was measured to be 0.0 vdc, indicating an electrical issue.The malfunctioning subcomponent could not be determined.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.(b)(4) follow-up report 1.
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Search Alerts/Recalls
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