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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNCARDIA SYSTEMS, LLC SYNCARDIA COMPANION HOSPITAL CART
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SYNCARDIA SYSTEMS, LLC SYNCARDIA COMPANION HOSPITAL CART Back to Search Results
Catalog Number 397003-001
Device Problems Component Falling (1105); Mechanical Problem (1384); Device Operates Differently Than Expected (2913)
Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)
Event Date 08/06/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
This syncardia companion hospital cart was not in patient use.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 reported that the companion hospital cart is in need of repair because the lcd monitor is about to fall off the mount at the tilt mechanism.This alleged failure mode poses a low risk to a patient because the hospital cart was not in use with a patient when the issue was observed.In addition, 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.
 
Manufacturer Narrative
The companion hospital cart was returned to syncardia for evaluation.Visual inspection of the hospital cart confirmed the reported issue of a loose display.The root cause was that one of the two screws which secured the display to the display neck hinge had fallen out.It was also noted during inspection that the display neck was difficult to swivel.Based upon the inspection of the display neck assembly, it is likely that additional force applied to the assembly to overcome the resistance to swiveling caused the screw to work loose and fall out during the course of normal use.The investigation could not determine what caused the display neck swivel difficulty.The swivel friction clamp was adjusted and the screws were reinstalled into the display, properly securing the display to the display hinge.After reassembly, the companion hospital cart passed all performance testing.This failure mode posed a low risk to a patient because the hospital cart was not in use with a patient when the issue was observed.In addition, it would not prevent a docked companion 2 driver from performing its life-sustaining functions.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).
 
Event Description
This syncardia companion hospital cart was not in patient use.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 reported that the companion hospital cart was in need of repair because the lcd monitor (display) was about to fall off the mount at the tilt mechanism.
 
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Brand Name
SYNCARDIA COMPANION HOSPITAL CART
Type of Device
HOSPITAL CART
Manufacturer (Section D)
SYNCARDIA SYSTEMS, LLC
1992 e. silverlake road
tucson AZ 85713
Manufacturer Contact
carole marcot
1992 e. silverlake road
tucson, AZ 85713
5205451234
MDR Report Key5888725
MDR Text Key53587266
Report Number3003761017-2016-00273
Device Sequence Number1
Product Code LOZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P030011
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation Other Health Care Professional
Remedial Action Repair
Type of Report Initial,Followup
Report Date 08/06/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/19/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number397003-001
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/09/2016
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/13/2016
Was Device Evaluated by Manufacturer? No
Date Device Manufactured11/19/2012
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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