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

Catalog Number 295025-001

Device Problem Charging Problem (2892)

Patient Problem No Patient Involvement (2645)

Event Date 06/27/2019

Event Type  malfunction  

Manufacturer Narrative

This alleged failure mode poses a low risk to a patient because the freedom onboard battery was not in patient use.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 in use by a patient.The customer, a syncardia certified hospital, reported that the freedom onboard battery would not charge.

Manufacturer Narrative

Investigation testing revealed the battery to be permanently disabled by its safety monitor most likely due to a cell over-voltage (cov) condition as indicated by the recorded max cell voltage of 4386mv which is approaching the secondary hardware protection device's activation threshold of 4400mv.Once this threshold is exceeded, the device instantly commands a permanent fault and permanently disables the battery making it unable to charge, confirming the customer-reported issue.The root cause for the cov fault is most likely typical aging/wear due to exposure to the high number of cycles.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) 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: 8791614
• MDR Text Key: 151127441
• Report Number: 3003761017-2019-00220
• 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: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 11/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2019
• 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: 07/09/2019
• Date Manufacturer Received: 06/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1