MAUDE Adverse Event Report: SYNCARDIA SYSTEMS, LLC CARDIOWEST TAH-T; ARTIFICIAL HEART

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Information (3190)

Event Date 12/25/2016

Event Type  malfunction  

Event Description

Patient was sleeping in hospital bed when total artificial heart (tah) driver began alarming.The driver continued to run the heart but the red alarm would not resolve.The driver was changed without difficulty by the bedside rns with assist from the ventricular assist device (vad) team via phone.

Event Description

Patient was sleeping in hospital bed when total artificial heart (tah) driver began alarming.The driver continued to run the heart but the red alarm would not resolve.The driver was changed without difficulty by the bedside rns with assist from the ventricular assist device (vad) team via phone.

• Brand Name: CARDIOWEST TAH-T
• Type of Device: ARTIFICIAL HEART
• Manufacturer (Section D): SYNCARDIA SYSTEMS, LLC; 1992 east silverlake rd.; tucson AZ 85713
• MDR Report Key: 7250830
• MDR Text Key: 99327089
• Report Number: 7250830
• Device Sequence Number: 1
• Product Code: LOZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial,Followup
• Report Date: 02/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 05/31/2019
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/01/2018
• Device Age: 4 MO
• Event Location: Hospital
• Date Report to Manufacturer: 02/08/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NO; NO
• Patient Age: 17155 DA
• Patient Weight: 250