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 Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/26/2020

Event Type  malfunction  

Manufacturer Narrative

The freedom car charger will be returned to syncardia for evaluation.The results will be provided in a follow-up mdr.(b)(4); 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 certified hospital, reported that the patient's freedom car charger did not work.There was no reported adverse patient impact.

Manufacturer Narrative

During investigation testing, the customer-reported issue was confirmed and reproduced as the car charger led would only illuminate when the cable was manipulated, indicating that there was an intermittent connection between the car charger and the cable.It cannot be conclusively determined what caused this intermittent connection to occur.This issue will be monitored and trended as part of the customer experience process.Syncardia has completed its investigation and is closing this file.Ce 5401 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 85713
• MDR Report Key: 10786738
• MDR Text Key: 214605971
• Report Number: 3003761017-2020-00226
• 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: 04/06/2021

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: 11/09/2020
• Initial Date Manufacturer Received: 10/26/2020
• Initial Date FDA Received: 11/04/2020
• Supplement Dates Manufacturer Received: 10/26/2020
• Supplement Dates FDA Received: 04/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 29 YR