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	09/09/2025
Type of Reportable Event	Malfunction

• 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 martins ; 1992 e silverlake road; tucson, AZ 85713 ; +1(520)545-1234
• MDR Report Key: 50862815
• Report Number: 3003761017-2025-00181
• Device Sequence Number: 10690357
• Product Code: LOZ
• UDI-Device Identifier: 00858000003121
• UDI-Public: (01)00858000003121
• Combination Product (Y/N): N
• Initial Reporter Country: SR
• 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: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 09/22/2026

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: 02/18/2026
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/22/2026
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown