Hi,

I do agree with the above discussion, Risk severity is categorized into three levels and includes a duration component. The three levels are medical device-related deaths or serious injuries, medical device-related non-serious adverse events, and medical device-related events without reported harm.
Likelihood of risk considers three risk factors related to the potential number of patients at risk of experiencing harm: the likelihood that a medical device will have problems, the likelihood of a patient experiencing harm, and the total number of patients exposed.