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

Catalog Number 295053-001

Device Problem Electrical /Electronic Property Problem (1198)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/08/2018

Event Type  malfunction  

Manufacturer Narrative

This alleged failure mode poses a low risk to the patient because it does not prevent the freedom driver from performing its life-sustaining functions.The freedom driver has a redundant power source of onboard batteries.The freedom car charger will be returned to syncardia for evaluation.The results of the evaluation will be provided in a follow-up mdr.(b)(4).

Event Description

The freedom car charger is 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.

Manufacturer Narrative

The customer-reported issue of the car charger not working was confirmed via the functional inspection, where the led did not illuminate and no voltage passed through the unit.Internal inspection of the car charger revealed a blown fuse.When the fuse was replaced with a fuse from a known operational freedom car charger, functionality was restored, including illumination of the status indicator led and passing 13.985vdc to the output of the device.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 CAR CHARGER
• Type of Device: CAR CHARGER
• Manufacturer (Section D): SYNCARDIA SYSTEMS, LLC; 1992 e. silverlake road; tucson AZ 85713
• MDR Report Key: 7995420
• MDR Text Key: 124815414
• Report Number: 3003761017-2018-00492
• 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: 12/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2018
• 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: 10/18/2018
• Date Manufacturer Received: 10/08/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 66 YR