Model Number 595000-001 |
Device Problems
Electrical /Electronic Property Problem (1198); Audible Prompt/Feedback Problem (4020)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/05/2021 |
Event Type
malfunction
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Manufacturer Narrative
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The freedom driver will be returned to syncardia for evaluation.The results 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 driver exhibited an intermittent fault alarm and unusual noise while supporting the patient.There was no reported adverse patient impact.The customer also reported that the patient was subsequently switched to a backup driver.
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Manufacturer Narrative
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The customer-reported "funny noise" was reproduced and during functional testing.The root cause was determined to be a malfunction of the primary motor as it made a grinding noise.This issue will be monitored and trended as part of the customer experience process.Syncardia has completed its investigation and is closing this file.(b)(4) follow-up report 1.
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Search Alerts/Recalls
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