MAUDE Adverse Event Report: SYNCARDIA TOTAL ARTIFICIAL HEART

Device Problems Device Operates Differently Than Expected (2913); Noise, Audible (3273)

Patient Problems Dyspnea (1816); Collapse (2416)

Event Date 09/24/2016

Event Type  Injury  

Event Description

I am on syncardia total artificial heart and had another machine failing.I had machine less than a week and was failing when i collapsed and had difficulty breathing.I was rushed to hospital and while changing out machine there replacement was making strange noises and was not able to be used.This has been an ongoing issue and scary for a device that is life saving.Failure of this can lead to my death and have had many issues with a number of machines.Something needs to be done to improve quality of these devices.

• Brand Name: TOTAL ARTIFICIAL HEART
• Type of Device: TOTAL ARTIFICIAL HEART
• Manufacturer (Section D): SYNCARDIA
• MDR Report Key: 5986458
• MDR Text Key: 56006505
• Report Number: MW5065070
• Device Sequence Number: 1
• Product Code: LOZ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 09/27/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention; Disability
• Patient Age: 62 YR
• Patient Weight: 100