Model Number 595000-001 |
Device Problem
Noise, Audible (3273)
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Patient Problems
No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/15/2020 |
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 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 driver was not supporting a patient at the time of the event.The customer, a syncardia certified hospital, reported that the freedom driver exhibited an unusual noise when the patient's wife turned it on.
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Manufacturer Narrative
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During investigation testing, the customer-reported abnormal sound was able to be reproduced.The root cause was determined to be a malfunction of the piston cylinder assembly.This issue will be monitored and trended as part of the customer experience process.Syncardia has completed its investigation and is closing this file.Ce 5323 follow-up report 1.
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Search Alerts/Recalls
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