Safety Alerts

The United Kingdom Medicines and Healthcare products Regulatory Agency (MHRA) has posted a medical device safety alert concerning Abbott Medical System Monitor [used with the HeartMate Left Ventricular Assist System (LVAS)] [Model Numbers: 1286, L1286, 1286A, L1286A, 1286INT and L1286INT] [HKMD number: 180052].

According to the MHRA, the manufacturer has received customer complaints for the System Monitor due to atypical screen display behaviors. All System Monitors can potentially show atypical screen display behaviors. Restarting the System Monitor should resolve these issues in most cases. There have not been any serious adverse health consequences associated with these complaints.

Some examples of atypical screen issues that may occur include:

• Overlapping screens/button
• Frozen screen
• Distorted text, blanks, or zeroes in place of values
• Unresponsive buttons where the user is unable to initiate a command.

For further information, please visit: https://mhra-gov.filecamp.com/s/d/M2AWgQErluvfs9iU

If you are in possession of the affected products, please contact your supplier for necessary actions.

Posted on 14 May 2024