Model Number 595000-001 |
Device Problem
Audible Prompt/Feedback Problem (4020)
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Patient Problem
No Patient Involvement (2645)
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Event Date 11/07/2018 |
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 the issue was observed while the driver was not supporting a patient.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.The customer, a syncardia certified hospital, reported that the freedom driver exhibited a fault alarm when an onboard battery was inserted.
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Manufacturer Narrative
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The customer-reported issue of a fault alarm upon start-up was confirmed via review of the driver's alarm history and testing.The alarm history was reviewed and revealed alarm codes produced as a result of the primary motor not engaging for greater than or equal to 5 seconds after continuous open or short detected.During investigation testing, the driver started up on the secondary motor and enunciated an alarm as designed.The root cause of the customer-reported issue was determined to be a malfunction of the main printed circuit board assembly (pcba) not powering the primary motor piston cylinder assembly (pca) triggering the driver to convert to secondary motor operation.Syncardia has a corrective and preventive action (capa) for this issue.Syncardia has completed its evaluation and is closing this file.Ce 4560 follow-up report 1.
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Search Alerts/Recalls
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