Acute clinical adverse events associated with the LUCAS chest compression system

Area of Science:

• Emergency Medicine
• Biomedical Engineering
• Patient Safety

Background:

• Mechanical cardiopulmonary resuscitation (CPR) devices, such as the Lund University Cardiac Assist System (LUCAS), aim to standardize chest compression quality and improve cardiac arrest outcomes.
• Increasing use of mechanical CPR necessitates understanding device-related complications to ensure patient safety.

Purpose of the Study:

• To analyze the nature and frequency of adverse events associated with LUCAS mechanical CPR devices.
• To identify trends and potential causes of device- and patient-related complications.

Main Methods:

• Retrospective analysis of adverse events reported to the US FDA MAUDE database for LUCAS devices (1.0 to 3.1) from 2015 to 2024.
• Manual review and categorization of events by device subtype and complication type (device-related vs. patient-related).

Main Results:

• A total of 255 adverse events were reported, showing an increasing trend.
• Device defects and power failures were the most common device-related issues.
• Patient complications included soft tissue injury, internal organ injury, and chest compression interruption.

Conclusions:

• Adverse events associated with LUCAS devices range from malfunction to serious patient harm, including death.
• Knowledge of common complications can guide operator training and mitigation strategies to enhance patient safety with mechanical CPR.