MAUDE Adverse Event Report: SynCardia Systems, LLC SynCardia Freedom Driver; External Pneumatic Driver

Catalog Number	P/N 595000-001
Medical Device Problem Code	Audible Prompt/Feedback Problem (4020)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/15/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Per hospital staff, patient called with unresolvable fault alarm.States fault alarm started after receiving a "3 beep" intermittent battery alarm, replaced a battery with a new one and driver immediately started fault alarming.Changed 2nd battery and alarm continued.No changes to tah parameters.States new batteries placed into freedom driver were fully charged.Patient switched driver without any reported adverse impact.

• Brand Name: SynCardia Freedom Driver
• Common Device Name: External Pneumatic Driver
• 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: alzira alzira ; 1992 e silverlake road; tucson, AZ 85713 ; +1(520)545-1234
• MDR Report Key: 50948642
• Report Number: 3003761017-2026-00201
• Device Sequence Number: 10348766
• Product Code: LOZ
• UDI-Device Identifier: 00858000003121
• 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): 09/29/2026

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 595000-001
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/24/2026
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 09/17/2026
• Initial Report FDA Received Date: 09/30/2026
• 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 Age: 27 YR
• Patient Sex: Male
• Patient Weight: 255 LB