Model Number 397002-001 |
Device Problem
Audible Prompt/Feedback Problem (4020)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 12/10/2018 |
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 reported issue did not prevent the companion 2 driver from performing 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 system malfunction alarm while supporting a patient.The customer also reported that the patient was switched to a backup companion 2 driver.There was no reported adverse patient impact.
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Manufacturer Narrative
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The customer-reported system malfunction alarm was confirmed upon review of the driver's alarm history and patient file data and was reproduced during investigation testing.The root cause was determined to be a malfunction of the main printed circuit assembly (pca), as there was evidence of cracks in the solder joints on the left vacuum connector.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) follow-up report 1.
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Search Alerts/Recalls
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