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

Catalog Number 295025-001

Device Problem Battery Problem (2885)

Patient Problem No Patient Involvement (2645)

Event Date 11/21/2018

Event Type  malfunction  

Manufacturer Narrative

This alleged failure mode poses a low risk to the patient because the reported issue was observed when the onboard battery was not supporting a patient.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 has been returned to syncardia for evaluation.The results of the investigation will be provided in a follow-up mdr.(b)(4).

Event Description

The customer, a syncardia certified hospital, reported that the freedom onboard battery had lost its ability to charge and would not show any led lights when in the charger.

Manufacturer Narrative

The customer-reported issue of the battery unable to charge was confirmed via review of the system management (smbus) data and functional testing of the battery which revealed that the battery's output had been disabled.The root cause for the battery's disabled output cannot be conclusively determined; however, analysis of the smbus recorded data indicates the battery was subjected to a deep discharge event, causing extreme cell under-voltage conditions.Because cell under-voltage parameters are outside of the internal safety firmware design limits, the battery's input/output functions have been permanently disabled.Syncardia has a corrective and preventive action (capa) to track and address any applicable actions related to permanently faulted onboard batteries.Syncardia has completed its evaluation of this complaint and is closing this file.Ce 4581 follow-up report 1.

• Brand Name: SYNCARDIA FREEDOM ONBOARD BATTERY
• Type of Device: BATTERY
• Manufacturer (Section D): SYNCARDIA SYSTEMS, LLC; 1992 e. silverlake road; tucson AZ 85713
• MDR Report Key: 8141556
• MDR Text Key: 129593658
• Report Number: 3003761017-2018-00545
• 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: 07/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2018
• 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: 11/28/2018
• Date Manufacturer Received: 11/21/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1