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

Model Number	295025-001
Medical Device Problem Code	Battery Problem (2885)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/19/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The customer, a syncardia certified hospital, reported that the patient's freedom onboard battery was not holding a charge for as long as the patient expected.There was no reported adverse patient impact.
Additional Manufacturer Narrative
During investigation testing, the battery's system management (smbus) calculated charge capacity was out of specification.The battery's internal processor calculates the battery's charge capacity based on data it logs for the cells over time.When the processor malfunctions, it is unable to accurately calculate the battery capacity leading to a shorter operation time.The root cause of customer-reported issue of the battery not holding a charge for as long as expected was determined to be defective internal processor board assembly.The battery cells themselves were working normally based on the individual voltages.This issue will be monitored and trended as part of the customer experience process.Syncardia has completed its investigation and is closing this file.Ce 5471 initial.

• Brand Name: SYNCARDIA FREEDOM ONBOARD BATTERY
• Common Device Name: 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: kerri hensley ; 1992 e. silverlake road; tucson, AZ 85713 ; 5205451234
• MDR Report Key: 13204995
• Report Number: 3003761017-2021-00223
• Device Sequence Number: 1581018
• Product Code: LOZ
• UDI-Device Identifier: 00858000003084
• UDI-Public: (01)00858000003084
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P030011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/06/2022

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
• Operator of Device: Lay User/Patient
• Device Model Number: 295025-001
• Device Catalogue Number: 295025-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/19/2021
• Initial Report FDA Received Date: 01/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/23/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Age: 56 YR
• Patient Sex: Male