Catalog Number 595000-001 |
Device Problems
Device Alarm System (1012); Device Operates Differently Than Expected (2913)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 11/28/2016 |
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 although the freedom driver exhibited a fault alarm, it continued to perform its life-sustaining functions.The freedom driver has been returned to syncardia for evaluation.The results of the investigation will be provided in a follow-up mdr.
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Event Description
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The customer, a syncardia certified hospital, reported that the freedom driver exhibited a fault alarm while supporting a patient.The customer also reported that the patient was switched to a back-up freedom driver without any adverse patient impact.
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Manufacturer Narrative
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The freedom driver was returned to syncardia for evaluation.The driver passed all pressure test requirements, which included cardiac output, rap (right atrial pressure), aop (aortic pressure), pap (pulmonary arterial pressure) and lap (left atrial pressure) performance metrics associated with nominal normotensive and hypertensive settings.Review of the electronic data revealed a fault code of "bottom pressure too high" which is indicative of a potentially failing u22 pressure sensor on the main pcba (printed circuit board assembly) and is consistent with the alarm that the customer experienced.Further investigation of the main pcba confirmed that the root cause for the reported fault alarm was a degraded pressure sensor (u22) on the main pcba.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.Ce 3603 follow-up report 1.
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Event Description
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The customer, a syncardia certified hospital, reported that the freedom driver exhibited a fault alarm while supporting a patient.The customer also reported that the patient was switched to a back-up freedom driver without any adverse patient impact.
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Search Alerts/Recalls
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