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

Catalog Number 397003-001

Device Problem Power Problem (3010)

Patient Problem No Patient Involvement (2645)

Event Date 02/20/2019

Event Type  malfunction  

Manufacturer Narrative

This alleged failure mode poses a low risk to a patient because the issue was observed when the companion hospital cart was not supporting a patient.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 companion hospital cart was not supporting a patient.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 hospital cart did not recognize ac power when plugged into the wall.

Manufacturer Narrative

The customer-reported issue of the hospital cart not recognizing power coming from the wall outlet was confirmed during functional testing when the companion 2 driver docked in the hospital cart did not turn on the ac power cord icon as designed.The root cause was determined to be the temperature proportional speed control feature of the u2 chip inducing noise along the enable lines of the u1 chip of the power control printed circuit board (pcb).Syncardia has a corrective and preventive action (capa) for this issue.Syncardia has completed its evaluation of this complaint and is closing this file.(b)(4).

• 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: 8432835
• MDR Text Key: 139214603
• Report Number: 3003761017-2019-00046
• 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: 04/25/2019

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: 03/05/2019
• Initial Date Manufacturer Received: 02/20/2019
• Initial Date FDA Received: 03/19/2019
• Supplement Dates Manufacturer Received: 02/20/2019
• Supplement Dates FDA Received: 04/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1