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

Catalog Number 295053-001

Device Problems Mechanical Problem (1384); Material Integrity Problem (2978)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/02/2018

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 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 connector became unscrewed.

Manufacturer Narrative

The customer-reported issue concerning the freedom car charger coming unscrewed could not be confirmed during this investigation.Despite the image provided by the customer, which depicts the car charger in a state of disassembly, the car charger that was returned to syncardia for investigation was fully assembled.Visual and functional inspection of the unit identified no damage or abnormalities.Both, the driver-side and vehicle-side, connection plugs of the car charging cable were subjected to inspection and each was verified to be properly assembled.While the reported issue could not be confirmed by inspection of the returned unit, it should be noted that the car charger is a serviceable component that incorporates a fuse cap on the vehicle-side connection plug that is designed to be unscrewed to permit replacement of the internal 12v fuse.The fuse cap on the returned unit was checked during the investigation and not found to be loose or unscrewed.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 FREEDOM CAR CHARGER
• Type of Device: CAR CHARGER
• Manufacturer (Section D): SYNCARDIA SYSTEMS, LLC; 1992 e. silverlake road; tucson AZ 85713
• MDR Report Key: 7774225
• MDR Text Key: 116874371
• Report Number: 3003761017-2018-00443
• 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: 09/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2018
• 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: 08/10/2018
• Date Manufacturer Received: 08/02/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 28 YR