MAUDE Adverse Event Report: SYNCARDIA COMPANION HOSPITAL CART

Catalog Number 397003-001

Device Problem Display or Visual Feedback Problem (1184)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/03/2021

Event Type  malfunction  

Manufacturer Narrative

The companion hospital cart will be returned to syncardia for evaluation.The results will be provided in a follow-up mdr.Ce 5495 initial.

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 display on the companion hospital cart had screen noise.

Manufacturer Narrative

The hospital cart was tested and met all functional requirements.Additional testing was performed on the lcd display and the reported problem was neither duplicated nor confirmed.The hospital cart performed as intended with no evidence of a device malfunction.The root cause of the customer-reported screen noise could not be determined.This issue will be monitored and trended as part of the customer experience process.Syncardia has completed its investigation and is closing this file.Ce 5495 follow-up report 1.

• Brand Name: SYNCARDIA COMPANION HOSPITAL CART
• Type of Device: HOSPITAL CART
• MDR Report Key: 11477493
• MDR Text Key: 247685698
• Report Number: 3003761017-2021-00036
• 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: 10/01/2021

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: 06/08/2021
• Initial Date Manufacturer Received: 03/03/2021
• Initial Date FDA Received: 03/12/2021
• Supplement Dates Manufacturer Received: 03/03/2021
• Supplement Dates FDA Received: 10/05/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/15/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1