MAUDE Adverse Event Report: SYNCARDIA SYSTEMS, LLC SYNCARDIA COMPANION 2 DRIVER; EXTERNAL PNEUMATIC DRIVER

Model Number 397002-001

Device Problem Display or Visual Feedback Problem (1184)

Patient Problem No Patient Involvement (2645)

Event Date 11/01/2019

Event Type  malfunction  

Manufacturer Narrative

This alleged failure mode poses low risk to a patient because the issue was observed when the companion 2 driver was not supporting a patient.The companion 2 driver 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 2 driver was not supporting a patient.The customer, a syncardia certified hospital, reported that the touch screen on the companion 2 driver was not responding.

Manufacturer Narrative

During initial incoming testing, the driver display was frozen at the ambulatory screen similar to the customer-reported issue.In order to perform functional testing, the driver was connected to a hospital cart and through the hospital cart setup screen, the driver touch screen was set for calibration.After the successful calibration of the driver touch screen, the driver's touch screen returned to normal operation.Ten power cycles were then performed where the driver touch screen successfully changed modes, patient settings, and menu modes with no anomalies observed.C2-900005, syncardia companion 2 driver system operator manual, explains both the driver screen and hospital cart screen calibration processes (section 8.1.10), and what to do if the driver touch screen is non-responsive (section 4.13).Using the steps as described in section 8.1.10 of c2-900005, the returned driver was successfully calibrated on using a hospital cart during this investigation.There was no evidence of a device a malfunction.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.Ce 5049 follow-up report 1.

• Brand Name: SYNCARDIA COMPANION 2 DRIVER
• Type of Device: EXTERNAL PNEUMATIC DRIVER
• Manufacturer (Section D): SYNCARDIA SYSTEMS, LLC; 1992 e. silverlake road; tucson AZ 85713
• MDR Report Key: 9345062
• MDR Text Key: 167172671
• Report Number: 3003761017-2019-00332
• Device Sequence Number: 1
• Product Code: LOZ
• UDI-Device Identifier: 00858000003107
• UDI-Public: (01)00858000003107
• 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: 12/05/2019

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 Model Number: 397002-001
• Device Catalogue Number: 397002-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2019
• Initial Date Manufacturer Received: 11/01/2019
• Initial Date FDA Received: 11/19/2019
• Supplement Dates Manufacturer Received: 11/01/2019
• Supplement Dates FDA Received: 12/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1