SCREEN ISSUES IN THE HEARTMATE SYSTEM MONITOR. FDA ALERT JUNE 2024 (+)

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Screen issues in the heartmate system monitor. June 2024.

 

The HeartMate System Monitor is a component of the HeartMate Left Ventricular Assist System. The System Monitor is used in the operating room or during clinic visits to...

Closely monitor system operation during lvad implant
Display information about system performance, including current operating mode, pump flow, pump speed, and overall operational status
Program system parameters such as pump speed
Assess and track alarm conditions
View and save performance data
And record data at specific intervals for review and analysis 
 

The company has alerted about an irregular behavior of the monitor screen.

These issues include screen freezing, overlapping buttons or screens, unresponsive buttons, distorted text or graphics, and incorrect or missing information on the display.

These problems can lead a clinician to unintentionally change pump settings or press the pump stop button.

 

We invite everybody to watch our youtube video for detailed and expanded information: 


 


  Tags: LVAD, heartmate, Heartmate 2, Heartmate 3, screen issues, problem, failure, system monitor, FDA recall, display, parameters, alarm, record, external peropheral console, EPC, freezing, overlapping, button, text, incorrect, missing, pump stop, hemodynamic, restart, connection. 

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