Medical Device Markings Issue

Issue associated with the written, printed or graphic material that is affixed to a medical device or any of its containers or wrappers or accompanying the device including verbal instructions, relating to identification, technical description, and usage which are provided by the device manufacturers. Issue can include but is not limited to this material being unclear, missing worn out, incorrect or inaccurate. (Food and Drug Administration)

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Medical Device Maintenance Issue

Issue associated with the servicing of a device.

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…

Medical Device Inoperable

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…