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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 Mechanical Problem (1384); Mechanics Altered (2984)
Patient Problems No Consequences Or Impact To Patient (2199); No Information (3190)
Event Date 01/12/2018
Event Type  malfunction  
Manufacturer Narrative
This alleged failure mode poses a low risk to a patient because the hospital cart did not prevent the 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.
 
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 neck bracket supporting the screen was loose and the screen was difficult to turn.
 
Manufacturer Narrative
The companion hospital cart was returned to syncardia for evaluation.Visual inspection and physical observation confirmed the customer-reported issues of a loose monitor neck and difficulty turning the monitor.The root cause of the loose neck supporting the monitor was a missing support screw.The reason for the missing screw cannot be conclusively determined; however, it is believed to be related to the difficulty rotating the monitor.The root cause of the difficulty to rotate the monitor was an overtightened friction clamp.Based upon the information provided by the customer, it cannot be conclusively determined how the friction clamp became overtightened; however, prior to leaving syncardia, during the assembly production check and quality check after final assembly, the tightness of the collar is checked and must be found to be within specifications before being shipped to the customer.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
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 neck bracket supporting the screen was loose and the screen was difficult to turn.
 
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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
michael garippa
1992 e. silverlake road
tucson, AZ 85713
5205451234
MDR Report Key7227696
MDR Text Key98853858
Report Number3003761017-2018-00041
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 Health Professional
Remedial Action Replace
Type of Report Initial,Followup
Report Date 01/15/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/30/2018
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 Manufacturer01/26/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received03/01/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/21/2012
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Age56 YR
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