Medical Device Maintenance Does not Comply to Manufacturers Recommendations

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 care of the device to sustain or restore acceptable operating conditions. (Food and Drug Administration)

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

Medical Device Incompatibility Problem

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

Medical Device Inappropriate Reset to Default

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

Medical Device Filtration Issue

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

Medical Device Failure to Shut Off

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

Medical Device Failure to Self-Test

Issue associated with the device failing to perform an internal self-diagnostic process to ensure normal operation during or prior to use. …