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

Catalog Number 397003-001

Device Problems No Display/Image (1183); Failure to Calibrate (2440); Physical Property Issue (3008)

Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)

Event Date 01/03/2018

Event Type  malfunction  

Manufacturer Narrative

This alleged failure mode poses a low risk to a patient because the hospital cart was not in use with a patient when the issue was observed.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) initial.

Event Description

This syncardia companion hospital cart was not in patient use.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 touchscreen on the companion hospital cart would not calibrate after repeated attempts.The customer also reported that companion 2 driver s/n (b)(4) (mfr.3003761017-2018-00016) was docked in this cart when the driver touchscreen would not calibrate.The customer also reported that the cart has a damaged neck bracket.

Manufacturer Narrative

The companion hospital cart was returned to syncardia for evaluation.The customer-reported issue of the hospital cart touch screen not able to calibrate was confirmed.The root cause was determined to be a malfunction of the lcd display.The customer-reported issue of a damaged neck bracket was also confirmed.The root cause was determined to be a missing fastening screw for the lcd display.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.(b)(4) follow-up report 1.

Event Description

This syncardia companion hospital cart was not in patient use.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 touchscreen on the companion hospital cart would not calibrate after repeated attempts.The customer also reported that companion 2 driver s/n (b)(4) (mfr.3003761017-2018-00016) was docked in this cart when the driver touchscreen would not calibrate.The customer also reported that the cart has a damaged neck bracket.

• 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: 7190021
• MDR Text Key: 97952363
• Report Number: 3003761017-2018-00015
• 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: 01/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2018
• 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: 01/09/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/07/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1