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	08/29/2022
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 at the time of the event.The customer, a syncardia authorized distributor, reported that the freedom onboard battery did not charge.
Event or Problem Description
The freedom onboard battery was not supporting a patient at the time of the event.The customer, a syncardia authorized distributor, reported that the freedom onboard battery did not charge.
Additional Manufacturer Narrative
Device history record (dhr) review confirmed that freedom onboard battery s/n (b)(6) was serviced and passed all functional testing prior to being released to finished goods.Battery data review found data could only be retrieved by connecting battery to a power supply, indicating negative communication within the battery.Review also retrieved a permanent fault code.Visual inspection of external components found no abnormalities.Visual inspection of internal components not available for battery.Battery failed incoming inspection due to negative communication, gas gauge leds not illuminating when button pressed, and inability to charge.Additional testing was performed resulting in a permanent fault code indicating battery will not complete and/or hold a charge.Failure investigation for this complaint confirmed reported issue.The complaint was replicated during testing; root cause of freedom onboard battery not charging determined to be permanent fault within battery.Failure investigation identified no other test failures or damage that could have contributed to the complaint.Battery was not in patient use at the time issue occurred.This issue will be monitored and trended as part of the customer complaint process.Syncardia has completed its evaluation and is closing this file.If new or additional information is received in the future, syncardia will file a follow-up mdr.

• 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: 15332324
• Report Number: 3003761017-2022-00099
• Device Sequence Number: 6486522
• Product Code: LOZ
• UDI-Device Identifier: 00858000003084
• UDI-Public: (01)00858000003084
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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: Foreign,Distributor
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 10/25/2023

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: 08/29/2022
• Supplement Date Received by Manufacturer: 08/29/2022
• Initial Report FDA Received Date: 08/31/2022
• Supplement Report FDA Received Date: 10/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/22/2019
• 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