MAUDE Adverse Event Report: SYNCARDIA SYSTEMS, LLC SYNCARDIA FREEDOM ONBOARD BATTERY

Catalog Number 295025-001

Device Problems Failure to Charge (1085); Device Inoperable (1663); Battery Problem (2885)

Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)

Event Date 11/24/2016

Event Type  malfunction  

Manufacturer Narrative

This alleged failure mode poses a low risk to a patient because the issue was observed when the freedom driver was not supporting a patient.In addition, it would not prevent the driver from performing its life-sustaining functions.In addition, patients are provided with several onboard batteries, and the freedom driver has a redundant power source of external wall power.The freedom onboard battery will be returned to syncardia for evaluation.The results of the investigation will be provided in a follow-up mdr.(b)(4).

Event Description

The freedom onboard battery was not supporting a patient.The customer, a syncardia certified hospital, reported that the freedom onboard battery did not work despite indicating that it was fully charged.

Manufacturer Narrative

The freedom onboard battery was returned to syncardia for evaluation.A functional evaluation utilizing a freedom driver test unit confirmed that the freedom driver onboard battery warning alarm will be triggered upon installation of freedom onboard battery s/n (b)(4) due to the lack of system management bus (smbus) communication.The freedom driver system is designed to alarm in the event that smbus communication with the freedom onboard batteries cannot be established as this could be an indication that one, or both, freedom onboard batteries are not installed in the driver as recommended.The customer-reported issue was confirmed.The root cause for the malfunction could not be conclusively determined because of the inability to access the smbus historic data.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.(b)(4).

Event Description

The freedom onboard battery was not supporting a patient.The customer, a syncardia certified hospital, reported that the freedom onboard battery did not work despite indicating that it was fully charged.

• Brand Name: SYNCARDIA FREEDOM ONBOARD BATTERY
• Type of Device: BATTERY
• Manufacturer (Section D): SYNCARDIA SYSTEMS, LLC; 1992 e. silverlake road; tucson AZ 85713
• Manufacturer Contact: carole marcot ; 1992 e. silverlake road; tucson, AZ 85713 ; 5205451234
• MDR Report Key: 6141104
• MDR Text Key: 61611327
• Report Number: 3003761017-2016-00378
• Device Sequence Number: 1
• Product Code: LOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/24/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 295025-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/27/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1