Catalog Number 397003-001 |
Device Problems
No Display/Image (1183); Device Operates Differently Than Expected (2913)
|
Patient Problem
No Consequences Or Impact To Patient (2199)
|
Event Date 09/18/2017 |
Event Type
malfunction
|
Manufacturer Narrative
|
This alleged failure mode poses a low risk to the patient because although lcd monitor was not working properly on the hospital cart, it would not prevent a docked companion 2 driver from performing its life-sustaining functions.The companion hospital cart will be returned to syncardia for evaluation.The results of the investigation will be provided in a follow-up mdr.(b)(4).
|
|
Event Description
|
The syncardia companion hospital cart is a large cart with wheels into which the syncardia companion 2 driver docks.It is intended for use in the hospital during the temporary total artificial heart (tah-t) implant procedure and subsequent recovery.The customer, a syncardia certified hospital, reported that the companion hospital cart lcd monitor was not working properly.There was no reported adverse patient impact.
|
|
Manufacturer Narrative
|
The companion hospital cart was returned to syncardia for evaluation.The customer-reported experience of the hospital cart main screen not working properly could not be confirmed or reproduced during investigation testing.Visual inspection of the hospital cart revealed no abnormalities and the cart passed all functional testing, which includes display functionality.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.(b)(4) follow-up report 1.
|
|
Event Description
|
The syncardia companion hospital cart is a large cart with wheels into which the syncardia companion 2 driver docks.It is intended for use in the hospital during the temporary total artificial heart (tah-t) implant procedure and subsequent recovery.The customer, a syncardia certified hospital, reported that the companion hospital cart lcd monitor was not working properly.There was no reported adverse patient impact.
|
|
Search Alerts/Recalls
|