MAUDE Adverse Event Report: SYNCARDIA SYSTEMS, LLC FREEDOM DRIVER SYSTEM; AC POWER ADAPTOR

Model Number P/N 295070-001

Device Problems Break (1069); Material Integrity Problem (2978)

Patient Problems Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/04/2023

Event Type  malfunction  

Event Description

Patient's mother reported to vad coordinator at vcu that power adaptor "had something broken on it".

Manufacturer Narrative

Device history record (dhr) review confirmed that freedom driver power adaptor (p/n 295070-001) s/n (b)(6) was serviced and passed all functional testing prior to being released to finished goods.Visual inspection of external components found damage; a piece of the mounting rail had broken off confirming customer complaint.Power adaptor passed incoming functional testing.Power adaptor is still fully functional but retained cosmetic damage.Failure investigation confirmed the customer reported issue.Complaint could not be replicated.The failure investigation found no evidence of a device malfunction.Patient was switched to a backup driver with no reported adverse impact.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 Description

Patient's mother reported to vad coordinator at vcu that power adaptor "had something broken on it".

• Brand Name: FREEDOM DRIVER SYSTEM
• Type of Device: AC POWER ADAPTOR
• Manufacturer (Section D): SYNCARDIA SYSTEMS, LLC; 1992 e. silverlake rd; 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: 17896709
• MDR Text Key: 325937747
• Report Number: 3003761017-2023-00129
• Device Sequence Number: 1
• Product Code: LOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Nurse
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date: 12/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: P/N 295070-001
• Device Catalogue Number: 295070-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/04/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 32 YR
• Patient Sex: Male