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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNCARDIA SYSTEMS, INC. SYNCARDIA COMPANION HOSPITAL CART
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SYNCARDIA SYSTEMS, INC. SYNCARDIA COMPANION HOSPITAL CART Back to Search Results
Catalog Number 397003-001
Device Problems Break (1069); Detachment Of Device Component (1104); No Display/Image (1183)
Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)
Event Date 02/04/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4) initial.
 
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 lcd monitor is damaged and detached from the bracket.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
(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 lcd monitor was damaged and detached from the bracket.The hospital cart was returned to syncardia for evaluation.Visual inspection of the exterior components confirmed the reported issue.There were two loose screws in the storage bin, which originally held the lcd monitor to the neck bracket.It is unknown how the screws became detached from their original mounting positions, as the screws showed evidence of loctite.It is possible that the lcd monitor was subjected to an impact shock.The inverter cable was also disconnected, which likely resulted from the displaced screws that allowed for the loose lcd monitor to pull on the inverter cable.Visual inspection of the interior components revealed that the usb cable was disconnected, which also likely resulted from the loose lcd monitor.The screws, lcd monitor and corresponding cables were replaced, and the hospital cart passed all final performance test requirements.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.The companion 2 driver is equipped with a touch screen that has the same functionality as the hospital cart touch screen.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.
 
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Brand Name
SYNCARDIA COMPANION HOSPITAL CART
Type of Device
HOSPITAL CART
Manufacturer (Section D)
SYNCARDIA SYSTEMS, INC.
1992 e. silverlake road
tucson AZ 85713
Manufacturer Contact
carole marcot
1992 e. silverlake road
tucson, AZ 85713
5205451234
MDR Report Key5437252
MDR Text Key38870928
Report Number3003761017-2016-00056
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 02/04/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/15/2016
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 Manufacturer02/16/2016
Is the Reporter a Health Professional? Yes
Date Manufacturer Received05/10/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/21/2013
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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