Failure Mode and Effects Analysis Application on a Home Mechanical Ventilation

There are currently a number of methods by which risks can be assessed, both in the health sector and in other sectors. The aim of this study is to apply a risk analysis to identify possible failures that may occur with individual parts of the lung ventilator used to provide home mechanical ventilation. The FMEA was used for risk assessment, where a team of service technicians was set up to calculate the risk priority number. Furthermore, Pareto analysis was used to determine the most frequent failure components. A total of 22 potential failures were identified. The most common causes of identified failures are clogging of components, exposure to inadequate thermal conditions, and mechanical damage caused by a human factor. Individual corrective actions have been proposed according to the identified causes and assigned evaluation. Turbine, microprocessor, alarm and battery failures account for 80% of all failures. Based on the results of the analysis, it is clear that persons who come into contact with the device must be sufficiently informed about the possible risks and be cautious when using the ventilator.