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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 Difficult to Insert (1316); Device Dislodged or Dislocated (2923)
Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)
Event Date 02/08/2018
Event Type  malfunction  
Manufacturer Narrative
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.The companion hospital cart has been 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 companion hospital cart was not supporting a patient.The customer, a syncardia certified hospital, reported that the locking power cord did not stay plugged into the hospital cart.
 
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 companion hospital cart was not supporting a patient.The customer, a syncardia certified hospital, reported that the locking power cord did not stay plugged into the hospital cart.
 
Manufacturer Narrative
The companion hospital cart was returned to syncardia for evaluation.Visual inspection and physical observation confirmed the customer-reported issue of the locking power cord unable to lock into place on the hospital cart.Investigation testing determined the root cause to be a damaged grounding pin, preventing a proper connection.The cause for this damage cannot be conclusively determined; however, it was likely caused by rough use causing excessive wear.This likely occurred by attempting to remove the cord without first disengaging the cord lock, which could have caused the scraping observed on the grounding pin.This issue will 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.
 
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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
MDR Report Key7319093
MDR Text Key101854955
Report Number3003761017-2018-00087
Device Sequence Number1
Product Code LOZ
Combination Product (y/n)N
PMA/PMN Number
P030011
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Remedial Action Replace
Type of Report Initial,Followup
Report Date 02/08/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/06/2018
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 Manufacturer02/12/2018
Was the Report Sent to FDA? No
Date Manufacturer Received04/17/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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