Medical Device Maintenance Issue

Issue associated with the non-compliance or non-performance to manufacturer specifications relating to device routine maintenance, i.e., periodic inspection, failure detection, repair, and…

Issue associated with the device being in a nonfunctional or inoperable state and cannot be used unless the causes of the inoperability…

Issue associated with the device not being compatible with another device component or substance (medication, body fluid etc) that it contains or…

Issue associated with the inability to appropriately perform or generate any automated setting if no specific selection has made by the…

Issue associated with the process of passing a substance through a porous medium, e.g., a blood clot filter for the removal of…

Issue associated with the device not powering off when a shut down was requested.