Model Number 397002-001 |
Device Problem
Image Display Error/Artifact (1304)
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Patient Problem
No Patient Involvement (2645)
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Event Date 02/14/2019 |
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 the issue was observed when the companion 2 driver was not supporting a patient.The companion 2 driver will be returned to syncardia for evaluation.The results of the evaluation 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 authorized distributor, reported that the companion 2 driver exhibited the boot action menu screen and not the expected user interface when it was turned on.The customer also reported that the machine took four to five minutes to turn off.
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Manufacturer Narrative
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The customer-reported issue of the companion 2 driver displaying the improper user interface at boot up was confirmed upon driver startup.The root cause of the bios menu being seen at driver startup was due to a deep cell depletion of the 3 volt cmos battery.When this occurs, the driver will not have the required voltage needed to maintain settings stored in the device memory, leading to a prompt to the user to reprogram the bios at boot up, as that data would be lost at each instance of power down without a functioning cmos battery.The root cause of the cmos battery reaching deep cell depletion could not be conclusively 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.Ce 4679 follow-up report 1.
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Search Alerts/Recalls
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