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

Catalog Number	295025-001
Medical Device Problem Code	Battery Problem (2885)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/27/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The freedom onboard battery will be returned to syncardia for evaluation.The results will be provided in a follow-up mdr.
Event or Problem Description
The freedom onboard battery was not supporting a patient.The customer, a syncardia certified hospital, reported that the freedom onboard battery did not work/charge to its fullest capacity.
Additional Manufacturer Narrative
The customer confirmed that they have lost the freedom onboard battery.Syncardia is closing this file.(b)(4).Follow-up report 1.
Additional Manufacturer Narrative
Device history record (dhr) review confirmed that freedom onboard battery (b)(6) was serviced and passed all functional testing prior to being released to finished goods.Battery data was reviewed and a permanent fault code was observed.Visual inspection of external components found no abnormalities.Visual inspection of internal components found no abnormalities.Battery failed incoming functional testing.Gas gauge leds would not illuminate when button was pressed.An additional test was performed on the battery to confirm it could hold a charge.Test confirmed permanent fault code indicating battery is not functional.Failure investigation for this complaint confirmed the reported issue; the root cause of the battery not holding a charge was a permanent fault code within the battery, rendering it inoperable.Root cause of the battery fault code could not be identified with the data available.Failure investigation identified no other test failures or damage that could have contributed to the complaint.Patient was switched to a backup driver without any reported adverse impact.
Event or Problem Description
The freedom onboard battery was not supporting a patient.The customer, a syncardia certified hospital, reported that the freedom onboard battery did not work/charge to its fullest capacity.

• 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: aaron meier ; 1992 e silverlake road; tucson, AZ 85713 ; 5205451234
• MDR Report Key: 14877779
• Report Number: 3003761017-2022-00060
• Device Sequence Number: 14910928
• Product Code: LOZ
• UDI-Device Identifier: 00858000003084
• UDI-Public: (01)00858000003084
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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,Followup,Followup
• Report Date (Section B): 10/12/2023

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: Health Professional
• Device Catalogue Number: 295025-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/02/2022
• Supplement Date Received by Manufacturer: 06/02/2022; 06/02/2022
• Initial Report FDA Received Date: 06/30/2022
• Supplement Report FDA Received Date: 09/07/2022; 10/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/01/2019
• 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 Sex: Unknown