MAUDE Adverse Event Report: SYNCARDIA SYSTEMS, LLC COMPANION 2 DRIVER; ARTIFICIAL HEART

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Cardiac Arrest (1762)

Event Date 04/07/2017

Event Type  malfunction  

Event Description

The companion driver stopped.A code was called after patient became unresponsive while sitting in chair after ambulating in-hall, not breathing, no pulse, seizures ambubag.The patient was placed on new driver.The patient stopped seizing, was alert and oriented, able to follow simple commands and move all extremities.Neuro consulted, and a patient was transferred to icu.

• Brand Name: COMPANION 2 DRIVER
• Type of Device: ARTIFICIAL HEART
• Manufacturer (Section D): SYNCARDIA SYSTEMS, LLC; 1992 e. silverlake road; tucson AZ 85713
• MDR Report Key: 6800058
• MDR Text Key: 82896430
• Report Number: 6800058
• 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: 08/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2017
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/10/2017
• Event Location: Hospital
• Date Report to Manufacturer: 08/10/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: CARDIAC DRUGS; NO