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

Catalog Number 295025-001

Device Problem Failure to Charge (1085)

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

Event Date 09/27/2016

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) initial.

Event Description

The freedom onboard battery was not supporting a patient.The customer reported that the freedom onboard battery does not charge.

Manufacturer Narrative

The freedom onboard battery was returned to syncardia for evaluation.Review of system management bus (smbus) data revealed intermittent cell 1 voltage data, intermittent cuv flags and intermittent charge/discharge functions.External power was applied with the battery presence signal activated.The onboard battery failed to charge, confirming the customer-reported issue.The root cause for freedom onboard battery exhibiting intermittent smbus data and failure to charge cannot be conclusively determined; however, the likely root cause is an intermittent cell 1 internal hardware connection.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 reported that the freedom onboard battery does not charge.

• 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: 5998426
• MDR Text Key: 57073062
• Report Number: 3003761017-2016-00338
• 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: 09/27/2016

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: Health Professional
• Device Catalogue Number: 295025-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/27/2016
• Initial Date FDA Received: 10/04/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/21/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2014
• 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