Model Number 397002-001 |
Device Problems
Incorrect, Inadequate or Imprecise Result or Readings (1535); 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 01/18/2017 |
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 a discrepancy between the right and left ventricle cardiac output (co) readings on the display, the companion 2 driver continued to perform its life-sustaining functions.The companion 2 driver will be returned to syncardia for evaluation.The results of the evaluation 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 companion 2 driver exhibited a discrepancy between the right and left ventricle cardiac output (co) readings on the display of the companion 2 driver while supporting a patient.The patient was subsequently switched to the backup companion 2 driver.There was no reported adverse patient impact.
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Manufacturer Narrative
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The companion 2 driver was returned to syncardia for evaluation.The customer-reported issue of a discrepancy in cardiac output and fill volumes was confirmed through review of the patient data file and reproduced during investigation testing.The root cause was determined to be a malfunction of the left and right valve assemblies.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.(b)(4).
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Event Description
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The customer, a syncardia certified hospital, reported that the companion 2 driver exhibited a discrepancy between the right and left ventricle cardiac output (co) readings on the display of the companion 2 driver while supporting a patient.The patient was subsequently switched to the backup companion 2 driver.There was no reported adverse patient impact.
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Search Alerts/Recalls
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