MAUDE Adverse Event Report: SYNCARDIA SYSTEMS, LLC SYNCARDIA FREEDOM CAR CHARGER

Catalog Number 295053-001

Device Problem Electrical /Electronic Property Problem (1198)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/28/2020

Event Type  malfunction  

Manufacturer Narrative

The freedom car charger will be returned to syncardia for evaluation.The results of the investigation will be provided in a follow-up mdr.Ce 5282 initial.

Event Description

The freedom car charger is a component that enables the freedom driver to be plugged into a 12v vehicle power outlet.The customer, a syncardia authorized distributor, reported that the patient's freedom car charger did not work.There was no reported adverse patient impact.

Manufacturer Narrative

During visual inspection, the green part of the connector was found to be pulled away from the connector body.However, this was proven to have no impact on the car charger's performance during investigational testing.During investigational testing, the car charger was found to be fully functional and the customer experience could not be reproduced.The root cause of the customer-reported issue could not be conclusively determined.The car charger performed as intended with no evidence of a device 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 (b)(4) follow-up report 1.

• Brand Name: SYNCARDIA FREEDOM CAR CHARGER
• Type of Device: CAR CHARGER
• Manufacturer (Section D): SYNCARDIA SYSTEMS, LLC; 1992 e. silverlake road; tucson, az
• MDR Report Key: 10068014
• MDR Text Key: 199135859
• Report Number: 3003761017-2020-00127
• 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: distributor,foreign
• Type of Report: Initial,Followup
• Report Date: 08/13/2020

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: Lay User/Patient
• Device Catalogue Number: 295053-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2020
• Initial Date Manufacturer Received: 04/28/2020
• Initial Date FDA Received: 05/18/2020
• Supplement Dates Manufacturer Received: 04/28/2020
• Supplement Dates FDA Received: 08/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 23 YR