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

Model Number 295025-001

Device Problems Battery Problem (2885); Appropriate Term/Code Not Available (3191)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/15/2021

Event Type  malfunction  

Manufacturer Narrative

The freedom onboard battery will be evaluated by syncardia.The results will be provided in a follow-up mdr.(b)(4) initial.

Event Description

While performing a routine evaluation, a syncardia technician reported that the freedom onboard battery was outside of the accepted full charge capacity deviation limit of 10%; the battery tested at 57%.A second test was performed to verify and the battery tested at 6% deviation.The battery was erratic in its performance.

Manufacturer Narrative

During investigation testing, the freedom onboard battery was retested and was found to be within the deviation limit of 10%.The battery performed as intended with no evidence of a device malfunction.The root cause of the initial reading outside of the deviation limit could not be conclusively determined.The initial reading could have been due to the battery not being fully seated within the test fixture.This issue will be tracked and trended as part of the customer complaint process.Syncardia has completed its investigation 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 (Section G): SYNCARDIA SYSTEMS, LLC; 1992 e. silverlake road; tucson AZ 85713
• Manufacturer Contact: sagar pimpalwar ; 1992 e. silverlake road; tucson, AZ 85713 ; 5205451234
• MDR Report Key: 12308020
• MDR Text Key: 266037864
• Report Number: 3003761017-2021-00153
• Device Sequence Number: 1
• Product Code: LOZ
• UDI-Device Identifier: 00858000003084
• UDI-Public: (01)00858000003084
• 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: Other
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 07/27/2022

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
• Device Model Number: 295025-001
• Device Catalogue Number: 295025-001
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 07/15/2021
• Initial Date FDA Received: 08/11/2021
• Supplement Dates Manufacturer Received: 07/15/2021
• Supplement Dates FDA Received: 08/08/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/26/2019
• 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