Model Number 397002-001 |
Device Problem
Audible Prompt/Feedback Problem (4020)
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Patient Problem
No Patient Involvement (2645)
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Event Date 11/14/2019 |
Event Type
malfunction
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Manufacturer Narrative
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This alleged failure mode poses a low risk to a patient because the issue was observed when the companion 2 driver was not supporting a patient.The companion 2 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 companion 2 driver was not supporting a patient.The customer, a syncardia certified hospital, reported that the companion 2 driver exhibited a single compressor malfunction alarm during check in.
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Manufacturer Narrative
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During investigation testing, the customer-reported single compressor malfunction alarm was confirmed and reproduced.The root cause was determined to be an open f2 fuse on the power management board.It cannot be conclusively determined what caused the fuse to open.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.Ce 5074 follow-up report 1.
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Search Alerts/Recalls
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