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

Device Problem Component Falling (1105)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/04/2016

Event Type  malfunction  

Event Description

We changed the freedom driver because patient reported freedom driver fell "approx.3 weeks ago from chair to hardwood floor".It was sent to syncardia mid-march and we received a report of "minor iatrogenic/recipient induced device malfunction ae".

• Brand Name: FREEDOM DRIVER
• Type of Device: ARTIFICIAL HEART
• Manufacturer (Section D): SYNCARDIA SYSTEMS, LLC; 1992 e. silverlake road; tucson AZ 85713
• MDR Report Key: 6449141
• MDR Text Key: 71376895
• Report Number: 6449141
• 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: 03/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Unknown
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/24/2017
• Event Location: Hospital
• Date Report to Manufacturer: 03/24/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NO; NO OTHER THERAPIES