Acute clinical adverse events associated with the LUCAS chest compression system.

Background: Mechanical cardiopulmonary resuscitation (CPR) devices, such as the Lund University Cardiac Assist System (LUCAS), were developed to reduce variability in the quality of chest compressions and improve outcomes of cardiac arrest. With increasing adoption of mechanical CPR devices, understanding the nature and frequency of device-related complications is critical to ensuring patient safety. Methods: This was a retrospective analysis of all adverse events involving the LUCAS 1.0, 2.0, 2.1, 2.2, 3.0 and 3.1 devices from 2015 to 2024 Manufacturer and User Facility Device Experience (MAUDE) maintained by the US Food and Drug -Administration. Reports were manually reviewed, categorized by device subtype, and further stratified by type of complication. Events were grouped into device- or patient-related categories to identify trends and potential causes. Results: A total of 255 adverse events were reported, with an increase from 12 events in 2015 to 33 in 2024. Most events were associated with LUCAS 1.0 (50.2 %) and LUCAS 2.0 (27.1 %). The most frequent device-related issues involved device defect (53.7 %) and power failure (26.7 %). Patient-related complications included soft tissue injury (22.0 %), internal organ injury (20.4 %), and chest compression interruption (13.7 %). Malfunctions such as abrupt stoppage, loss of suction, or misalignment were frequently noted as contributing factors. Conclusion: Reported adverse events associated with LUCAS use include device malfunction and deployment issues, with serious patient harm including death or organ injury, in some cases. As mechanical CPR becomes more widely adopted, knowledge of the most common complications can inform operator training and potential mitigating strategies to minimize adverse outcomes.