Failure to Back-Up Software Problem Associated with Medical Device

Issue associated with the inability to backup or to retrieve a backed up version (corrupted file) of device data or system files. (Food and Drug Administration)

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Failure to Align Medical Device Problem

Issue associated with a circuit, equipment, or system whereby its functions fail to be properly synchronized or its relative positions properly…

Failure to Advance Medical Device Problem

Issue associated with failure to move the device or its components to an intended location.

Failure of Cardiac Pacemaker to Pace

Failure to pace manifests as absence of pacemaker stimulation artifacts on electrocardiographic recordings despite rates below pacemaker programmed rate.

Failure of Cardiac Pacemaker to Capture

Failure to capture manifests as a high pacing threshold that results in either intermittent failure to capture at maximal programmed output or…

Failure After Multiple Treatments

A lack of response to more than one cycle of therapy.

Failure After First Treatment

A lack of response to the first cycle of therapy.