Catalog Number 397001-001 |
Device Problems
Mechanical Problem (1384); Device Operates Differently Than Expected (2913)
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Patient Problems
No Patient Involvement (2645); No Information (3190)
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Event Date 03/26/2018 |
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.(b)(4).
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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 authorized distributor, reported that the companion 2 driver locking mechanism does not work.
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Manufacturer Narrative
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Corrected data: device manufacture date has been corrected to 18-feb-2013.Visual inspection confirmed the customer-reported issue of the companion 2 driver locking mechanism not working properly as the release plunger assembly was observed to be stuck in the open position.This is a known issue that has been previously documented and investigated; it determined that a lack of internal lubrication was the root cause for the release plunger assembly to be stuck in the open or closed positions.The device history records review of companion caddy s/n (b)(4) indicated that the release plunger assembly was installed prior to the most current drawing, and was therefore replaced in accordance with the caddy service shop order when it was returned from the field.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.(b)(4) follow-up report 1.
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Manufacturer Narrative
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Corrected data: device manufacture date has been corrected to 18-feb-2013.Visual inspection confirmed the customer-reported issue of the companion 2 driver locking mechanism not working properly as the release plunger assembly was observed to be stuck in the open position.This is a known issue that has been previously documented and investigated; it determined that a lack of internal lubrication was the root cause for the release plunger assembly to be stuck in the open or closed positions.The device history records review of companion caddy s/n (b)(4) indicated that the release plunger assembly was installed prior to the most current drawing, and was therefore replaced in accordance with the caddy service shop order when it was returned from the field.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.(b)(4) follow-up report 1.
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Search Alerts/Recalls
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