Misclassification: The detection and classification is related to confidence intervals, thus especially for low confidence intervals a misclassification or misinterpretation of the ECG, resulting in under- or overdiagnosis, might be possible.
Loss of service: PMcardio's services or parts of its functions may be interrupted or unavailable due to technical problems (e.g. cybersecurity attacks, system errors, connectivity issues), incorrect use or internet outages. An internet connection is required at all times. In case of time-critical decisions in an environment with poor connectivity, uploading an ECG report, analyzing, and consultation with other users may be delayed or even fail altogether.
Wrong information provided by the user: The answers requested by the anamnestic questions in the app are used to further narrow down the diagnosis and establish immediate patient management recommendations. Inadequate information provided by the user may result in inappropriate patient management recommendations.
Wrong format or ECG settings selected: The correct selection of the format and the respective settings of the ECG is crucial to allow for a correct analysis and diagnosis of the ECG. Selecting the wrong format may lead to erroneous output or a misinterpretation of the ECG recording.