Model Number 295025-001 |
Device Problem
Mechanical Problem (1384)
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Patient Problems
No Consequences Or Impact To Patient (2199); Patient Problem/Medical Problem (2688)
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Event Date 06/24/2019 |
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 it did not prevent the freedom driver from performing its life sustaining functions.In addition, patients are provided with several onboard batteries, and the freedom driver has a redundant power source of external wall power.The freedom onboard battery 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 customer, a syncardia certified hospital, reported that the freedom onboard battery was returned with a damaged connector.There was no reported adverse patient impact.
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Manufacturer Narrative
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Physical inspection confirmed battery housing/connector separation.As there was no physical evidence or reported event that could be attributed to causing the housing damage, no root cause could be conclusively established.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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