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

Catalog Number 295025-001

Device Problems Battery Problem (2885); Charging Problem (2892); Power Problem (3010)

Patient Problems No Consequences Or Impact To Patient (2199); No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)

Event Date 09/21/2017

Event Type  malfunction  

Manufacturer Narrative

This alleged failure mode poses a low risk to a patient because the issue was observed when the freedom onboard battery was not supporting a patient.The freedom onboard battery will be returned to syncardia for evaluation.The results of the investigation will be provided in a follow-up mdr.Ce 3980 initial.

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 hold a charge.

Manufacturer Narrative

The battery was returned in an over-discharged state requiring use of the built-in zero-voltage-charge (zvchg) recovery utility.The over-discharge condition would have caused the customer-reported issue of being unable to hold a charge.The root cause for the over-discharged condition was that the battery was allowed to become discharged and never received a maintenance charge.The battery was successfully recovered by use of the built-in zvchg recover utility and was tested in accordance with the current evaluation process where it successfully passed all sections.This issue will continue to be monitored and trended as part of the customer experience process.Syncardia has completed its evaluation 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
• Manufacturer Contact: kerri hensley ; 1992 e. silverlake road; tucson, AZ 85713 ; 5205451234
• MDR Report Key: 6907594
• MDR Text Key: 89695544
• Report Number: 3003761017-2017-00191
• 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: 09/13/2018

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: Other Health Care Professional
• Device Catalogue Number: 295025-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/21/2017
• Initial Date FDA Received: 10/02/2017
• Supplement Dates Manufacturer Received: 09/21/2017
• Supplement Dates FDA Received: 09/17/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2015
• 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