Model Number 595000-001 |
Device Problem
Electrical /Electronic Property Problem (1198)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 10/04/2018 |
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 although the ac power adaptor on the freedom driver exhibited a blinking light, it did not prevent the freedom driver from performing 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).
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Event Description
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The customer, a syncardia certified hospital, reported that the ac power adaptor on the freedom driver exhibited a blinking light while plugged in.The customer also reported that the patient was switched to a backup freedom driver without any adverse patient impact.
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Manufacturer Narrative
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The customer-reported blinking led on the power adaptor of the freedom driver was not able to be confirmed or reproduced during investigation testing.The power adaptor and the driver passed all functional tests.The freedom driver performed as intended with no evidence of a device malfunction.Despite the customer-reported issue not being confirmed or able to be reproduced, syncardia has a corrective and preventive action (capa) for this issue.Syncardia has completed its evaluation and is closing this file.(b)(4) follow-up report 1.
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Search Alerts/Recalls
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