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

Catalog Number 295025-001

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

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 05/15/2018

Event Type  malfunction  

Manufacturer Narrative

This alleged failure mode poses a low risk to the patient because although the freedom onboard battery would not hold a charge, 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 patient's freedom onboard battery would not hold a charge.

Manufacturer Narrative

The cause for the customer-reported issue of the freedom onboard battery unable to charge is that the battery exhibited a permanent fault and was permanently disabled by its internal safety monitor.Since no system management (smbus) communications could be established, analysis of the permanent fault could not be performed and root cause could not be conclusively determined.Syncardia has a corrective and preventive action (capa) to address the inability of the user to detect when a freedom onboard battery is disabled.Syncardia has completed its evaluation of this complaint and is closing this file.Ce 4317 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: 7566363
• MDR Text Key: 110197204
• Report Number: 3003761017-2018-00207
• 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
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 05/17/2019

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: Lay User/Patient
• Device Catalogue Number: 295025-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/21/2018
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/15/2018
• Initial Date FDA Received: 06/04/2018
• Supplement Dates Manufacturer Received: 05/15/2018
• Supplement Dates FDA Received: 05/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 48 YR