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

Catalog Number 397003-001

Device Problem No Display/Image (1183)

Patient Problems No Patient Involvement (2645); Patient Problem/Medical Problem (2688)

Event Date 08/29/2018

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 will be 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 display on the hospital cart was blank.

Manufacturer Narrative

The hospital cart passed functional testing, but additional testing was able to reproduce the customer-reported issue of the screen going blank.The investigation determined the root cause to be a malfunction of the lcd display module likely caused by the lcd printed circuit board (pcb) inverter not having the insulator behind it.This is a known issue that has been previously documented and investigated.All hospital carts returned to syncardia are evaluated and the lcd displays without the insulator are replaced during the hospital cart service procedure.This issue will continue to be monitored and trended as part of the customer experience process.Syncardia has completed its evaluation and is closing this file.(b)(4) 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: 7862172
• MDR Text Key: 119808586
• Report Number: 3003761017-2018-00458
• 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: 10/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2018
• 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: 09/10/2018
• Date Manufacturer Received: 08/29/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1