Model Number 595000-001 |
Device Problems
Defective Alarm (1014); 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 08/28/2016 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4) initial.
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Event Description
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The customer reported that the freedom driver exhibited multiple fault alarms while supporting a patient.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 exhibited fault alarms, 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 customer-reported issue of multiple fault alarms could not be confirmed or reproduced during investigation testing.The driver passed all test sections and pressure performance metrics associated with normotensive and hypertensive settings.Additionally, an extended observation run was performed, during which the driver functioned as intended with no anomalies or unintended alarms.There was no evidence of a device malfunction.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 exhibited multiple fault alarms while supporting a patient.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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