MAUDE Adverse Event Report: SYNCARDIA SYSTEMS, LLC SYNCARDIA COMPANION HOSPITAL CART

Catalog Number 397003-001

Device Problems Electrical /Electronic Property Problem (1198); Image Display Error/Artifact (1304)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/02/2019

Event Type  malfunction  

Manufacturer Narrative

This alleged failure mode poses a low risk to the patient because it 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 evaluation 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 monitor on the hospital cart stopped working while supporting a patient.

Manufacturer Narrative

The customer-reported experience of the hospital cart display that "stopped working" could not be confirmed or reproduced during the investigation testing.Visual inspection of the hospital cart did not reveal any damage or 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.Ce 4730 follow-up report 1.

• 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 Key: 8519830
• MDR Text Key: 142115631
• Report Number: 3003761017-2019-00074
• Device Sequence Number: 1
• Product Code: LOZ
• Combination Product (y/n): N
• PMA/PMN Number: P030011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 05/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 397003-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2019
• Initial Date Manufacturer Received: 04/02/2019
• Initial Date FDA Received: 04/16/2019
• Supplement Dates Manufacturer Received: 04/02/2019
• Supplement Dates FDA Received: 05/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 59 YR