MAUDE Adverse Event Report: SynCardia Systems, LLC SynCardia Freedom Onboard 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	05/05/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Per hospital staff, freedom onboard battery s/n (b)(6) will not charge.Battery has been placed in multiple charging ports on charger and reportedly will not charge.No adverse impact to patient reported.

• 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: michael larsen ; 1992 e silverlake road; tucson, AZ 85713 ; +1(520)545-1234
• MDR Report Key: 50790148
• Report Number: 3003761017-2025-00104
• Device Sequence Number: 10570912
• Product Code: LOZ
• UDI-Device Identifier: 00858000003084
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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
• Report Date (Section B): 09/15/2026

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: Health Professional
• Device Expiration Date: 03/17/2026
• Device Catalogue Number: P/N 295025-001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 05/05/2025
• Initial Report FDA Received Date: 09/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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