Model Number 397002-001 |
Device Problems
Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
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Event Date 08/14/2017 |
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 companion 2 driver exhibited an alarm, the companion 2 driver continued to perform its life-sustaining functions.The companion 2 driver has been returned to syncardia for evaluation.The results of the evaluation will be provided in a follow-up mdr.
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Event Description
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The customer, a syncardia authorized distributor, reported that the companion 2 driver exhibited a very low left cardiac output alarm while supporting a patient.The customer also reported that the patient was switched to a backup driver without adverse impact.
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Manufacturer Narrative
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The companion 2 driver was returned to syncardia for evaluation.The electronic patient data were reviewed and confirmed the customer-reported issue.During investigation testing, the very low left cardiac output alarm and drop in left fill volume was reproduced and the root cause was determined to be a malfunction of the left pilot valve.Syncardia has a corrective and preventive action (capa) for this issue.Syncardia has completed its evaluation of this complaint and is closing this file.(b)(4) follow-up report 1.
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Event Description
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The customer, a syncardia authorized distributor, reported that the companion 2 driver exhibited a very low left cardiac output alarm while supporting a patient.The customer also reported that the patient was switched to a backup driver without adverse impact.
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Search Alerts/Recalls
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