Model Number 595000-001 |
Device Problems
Device Issue (2379); 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 06/05/2017 |
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 freedom driver exhibited a fault alarm, it continued to perform its life-sustaining functions.The freedom driver has been returned to syncardia for evaluation.The results of the investigation will be provided in a follow-up mdr.(b)(4) initial.
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Event Description
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The customer, a syncardia certified hospital, reported that the freedom driver exhibited a fault alarm while supporting a patient.The customer also reported that the patient switched to a back-up freedom driver without any reported adverse patient impact.
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Manufacturer Narrative
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The freedom driver was returned to syncardia for evaluation.The driver in "as received" condition passed all test requirements and performed as intended and with 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, a (b)(6) hospital, reported that the freedom driver exhibited a fault alarm while supporting a patient.The customer also reported that the patient switched to a back-up freedom driver without any reported adverse patient impact.
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Search Alerts/Recalls
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