## 6 Conclusions  
With the application of the proposed method, it was possible to obtain timed models that allow for the supervision of the dynamic behavior of adverse processes initiated by the occurrence of AEs. The digitization of the adverse process promptly enables communication between the medical team and other entities, improving care for patients with implanted VADs. This way, it is possible to minimize patient harm and assess the risks associated with AEs.  
In this context, a modular, event-oriented structure was established, allowing the medical team to monitor the dynamic evolution of unwanted states and supervise patient care processes, initiating interventions as needed.  
The system's entities were organized to support horizontal and vertical integration. These are fundamental characteristics for implementing a system geared towards the Health 4.0 context [51; 52], where collaborative interaction occurs between the VAD, the patient, and the supervising medical team.  
With the presented results, new diagnostic and mitigation modules can be specified for the progression of the new adverse process. These are essential for health regeneration and significantly contribute to reducing the risk of death for patients with implanted VADs.  
Therefore, the SCVAD provides a structure that allows the medical team to address the needs of patients, based on knowledge of adverse processes, as well as to specify new adverse processes identified within the community of patients with implanted VADs. This work aims to contribute to the development of supervision systems that align with new technologies present in the Industry 4.0 context [20] and to address the exclusive demands of an open system that fosters collaborative interaction among medical devices embedded in patients, the patients themselves, and medical teams, for the formulation of future intelligent systems geared towards Health 4.0 capable of meeting specific requirements for each patient.  
Conceptualization, J.R.C.S.S., M.A.O.P. and D.J.S.F.; data curation, J.R.C.S.S., M.A.O.P. and D.J.S.F.; formal analysis, J.R.C.S.S., M.A.O.P. and D.J.S.F.; investigation, J.R.C.S.S., M.A.O.P. and D.J.S.F.; methodology, J.R.C.S.S., M.A.O.P. and D.J.S.F.; project administration, J.R.C.S.S., M.A.O.P. and D.J.S.F.; resources, M.A.O.P., F.J., P.E.M. and D.J.S.F.; supervision, M.A.O.P. and D.J.S.F.; validation, J.R.C.S.S., M.A.O.P. and D.J.S.F.; visualization, J.R.C.S.S., M.A.O.P., F.J., P.E.M. and D.J.S.F.; writing--original draft preparation, J.R.C.S.S., M.A.O.P. and D.J.S.F.; writing--review and editing, J.R.C.S.S., M.A.O.P. and D.J.S.F. All authors have read and agreed to the published version of the manuscript.  
This research was supported by the Sao Paulo Research Foundation (FAPESP)-BPE grant n\({}^{\text{o}}\) 2013/24434-0 and by the CAPES Graduate Studies Support Program (PROAP 2050/2022-PPGEM/EPUSP), which supported the research leading to this publication.  
Not applicable.  
The following abbreviations are used in this manuscript:  
A. Adverse event  
A. American Heart Association  
A. Application programming interfaces  
B. Bridge to recovery  
B. Bridge to transplant  
C. Critical system  
D. Discrete-event system  
D. Digital model for adverse event diagnosis  
D. Digital model for adverse process mitigation  
D. Destination therapy  
E. Event-driven architecture  
FDA. Food and Drug Administration  
HAZOP. Hazard and operability studies  
H. Heart failure  
HM2. HeartMate 2  
HM3. HeartMate 3  
MDR. Medical device report  
P.S. Production flow schema  
PN. Petri nets  
System for supervising critical adverse processes in patients with implanted  
ventricular assist devices  
V.D. Ventricular assist device