Catalog Number 397001-001 |
Device Problem
Electrical /Electronic Property Problem (1198)
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Patient Problem
No Patient Involvement (2645)
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Event Date 09/20/2018 |
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 driver caddy was not supporting a patient.The companion driver caddy will be returned to syncardia for investigation.The results of the investigation will be provided in a follow-up mdr.Ce (b)(4) initial.
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Event Description
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The companion driver caddy was not in use by a patient.The companion driver caddy is a small cart with wheels into which the companion 2 driver docks.It is designed to facilitate mobility of stable patients while in the hospital.The caddy can be plugged into external wall power to provide a redundant power source to the docked companion 2 driver.The customer, a syncardia certified hospital, reported that the companion driver caddy had a power connectivity issue since the docked companion 2 driver would only run on its internal battery and not wall power.
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Manufacturer Narrative
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The customer-reported issue of the driver only able to run off the emergency backup battery while docked in the caddy was confirmed during investigation testing.The root cause was determined to be a malfunction of the caddy's power supply which was unable to output adequate voltage.This lack of power could lead to the driver not charging the external batteries (no external power going to the driver).This issue will continue to be monitored and trended as part of the customer experience process.Syncardia has completed its evaluation and is closing this file.Ce 4478 follow-up report 1.
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Search Alerts/Recalls
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