MAUDE Adverse Event Report: SYNCARDIA SYSTEMS INC FREEDOM DRIVER; ARTIFICIAL HEART

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Code Available (3191)

Event Date 03/13/2016

Event Type  malfunction  

Event Description

Patient's freedom driver went into a permanent fault alarm; switched patient to the back up driver without any issues.

• Brand Name: FREEDOM DRIVER
• Type of Device: ARTIFICIAL HEART
• Manufacturer (Section D): SYNCARDIA SYSTEMS INC; 1992 e. silverlake rd.; tucson, AZ 85713
• MDR Report Key: 5528819
• MDR Text Key: 41236133
• Report Number: 5528819
• Device Sequence Number: 1
• Product Code: LOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Other Device ID Number: CONTROL #L157264
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/14/2016
• Event Location: Hospital
• Date Report to Manufacturer: 03/14/2016
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/28/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 31 YR