MAUDE Adverse Event Report: SYNCARDIA SYSTEMS, LLC SYNCARDIA FREEDOM DRIVER BATTERIES; BATTERY

Catalog Number	P/N 295025-001
Medical Device Problem Code	Charging Problem (2892)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/14/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Per hospital staff, patient was seen in the clinic and brought two freedom driver batteries and stated that they will not charge.No adverse impact to patient was reported.
Additional Manufacturer Narrative
Device history record (dhr) review confirmed that freedom driver battery (b)(6) was serviced and passed all functional testing prior to being released to finished goods.Battery alarm review found recorded, a permanent fault status of "0001".Visual inspection of external components found separation between housings.Functional testing found that battery s/n (b)(6) failed due to separation of the housing and due to the battery not charging.Additional testing included confirming the initial smbus data, no changes were found.Battery s/n (b)(6) recorded a permanent fault status of "0001".Customer complaint was replicated.Failure investigation for this complaint confirmed the reported issue.The customer complaint was replicated during testing; the root cause of the reported inability of the battery to charge was determined to be a permanent battery fault due to exposure to overvoltage during regular use.Failure investigation identified no other test failures or damage that could have contributed to the reported event.No adverse impact to patient reported.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.
Event or Problem Description
Per hospital staff, patient was seen in the clinic and brought two freedom driver batteries and stated that they will not charge.No adverse impact to patient was reported.

• Brand Name: SYNCARDIA FREEDOM DRIVER BATTERIES
• 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: michael larsen ; 1992 e silverlake road; tucson, AZ 85713 ; 5205451234
• MDR Report Key: 24317740
• Report Number: 3003761017-2026-00081
• Device Sequence Number: 20043226
• Product Code: LOZ
• UDI-Device Identifier: 00858000003084
• UDI-Public: (01)00858000003084
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 04/23/2026

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 Catalogue Number: P/N 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: 11/14/2025
• Supplement Date Received by Manufacturer: 11/14/2025
• Initial Report FDA Received Date: 02/11/2026
• Supplement Report FDA Received Date: 04/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: 36 YR
• Patient Sex: Male