MAUDE Adverse Event Report: SYNCARDIA COMPANION HOSPITAL CART

Catalog Number 397003-001

Device Problems Display or Visual Feedback Problem (1184); Appropriate Term/Code Not Available (3191)

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

Event Date 04/13/2020

Event Type  malfunction  

Manufacturer Narrative

The companion hospital cart has been returned to syncardia for evaluation.The results 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 companion hospital cart was defective.No additional information was provided.

Manufacturer Narrative

During investigation testing, electrical noise was observed emanating from the lcd display; this is most likely the customer-reported "defect".The lcd module display met all functional requirements for incoming testing.The root cause of the electrical noise was determined to be that the display precedes a design change that implemented an electrical insulator between the touchscreen backlight inverter printed circuit assembly (pca) and the metal mounting bracket.The electrical noise can impact the display readings; although, in this case, information was readable.This issue will be monitored and trended as part of the customer experience process.Syncardia has completed its investigation and is closing this file.(b)(4) follow-up report 1.

• Brand Name: SYNCARDIA COMPANION HOSPITAL CART
• Type of Device: CART
• MDR Report Key: 12329110
• MDR Text Key: 266892960
• Report Number: 3003761017-2021-00158
• 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: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 09/17/2021

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: 08/12/2021
• Initial Date Manufacturer Received: 07/19/2021
• Initial Date FDA Received: 08/16/2021
• Supplement Dates Manufacturer Received: 07/19/2021
• Supplement Dates FDA Received: 09/21/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/10/2010
• 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