Catalog Number 595000-001 |
Device Problems
Low Readings (2460); Device Displays Incorrect Message (2591)
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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 03/27/2016 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).
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Event Description
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The customer reported that the freedom driver displayed a lower cardiac output (co).The customer also reported that the patient was subsequently switched to the backup freedom driver.There was no reported adverse patient impact.This alleged failure mode poses a low risk to the patient because although the freedom driver displayed a lower cardiac output, the freedom driver continued to perform its life-sustaining functions.The freedom driver will be returned to syncardia for evaluation.The results of the investigation will be provided in a follow-up mdr.
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Manufacturer Narrative
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The freedom driver was returned to syncardia for evaluation the driver passed all functional test requirements with no anomalies or alarms.Additionally, an extended observation run was performed on the primary motor circuit and the driver functioned as intended with no evidence of a device malfunction.The customer reported low cardiac output could not be reproduced during investigation testing; therefore, a root cause for the reported issue could not be determined.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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Event Description
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The customer reported that the freedom driver displayed a lower cardiac output (co).The customer also reported that the patient was subsequently switched to the backup freedom driver.There was no reported adverse patient impact.
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Search Alerts/Recalls
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