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

Device Problems Device Displays Incorrect Message (2591); Device Sensing Problem (2917); Pressure Problem (3012)

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

Event Date 05/25/2016

Event Type  Injury  

Event Description

"patient had been experiencing frequent red fault alarms with coughing that resolved in a few seconds.However at 0057 pt had persistant red fault alarm that occurred when pt was resting comfortably in chair.Efforts to troubleshoot no change alarm continued.Pt vs stable.At 0117 instructed by md to exchange driver.Changed without incident to back-up driver.New back up obtained from stock.The (b)(4) - returned to syncardia.The (b)(4) now primary.The (b)(4) now back-up.

• Brand Name: SYNCARDIA FREEDOM DRIVER
• Type of Device: SYNCARDIA FREEDOM DRIVER, TOTAL ARTIFICIAL HEART
• Manufacturer (Section D): SYNCARDIA SYSTEMS INC. ; 1992 e. silver lake rd.; tucson AZ 85713
• MDR Report Key: 5829670
• MDR Text Key: 50732020
• Report Number: 5829670
• Device Sequence Number: 1
• Product Code: LOZ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 07/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/25/2016
• Distributor Facility Aware Date: 07/20/2016
• Event Location: Hospital
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 37 YR
• Patient Weight: 143