Failure to Unwrap Medical Device Problem

Issue associated with problems removing the materials used to construct the cover or outer wrapping of the device. (Food and Drug Administration)

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Failure to Thrive

A clinical finding indicating less than normal growth in an infant or child, or a state of global decline in an…

Failure to Spike Medical Device Problem

Failure of device to generate a correctly-shaped pacing output, for example, a waveform that is too wide.

Failure to Shock with Inadequate Defibrillator Threshold Safety Margin

The cardiac lead failed to administer a shock and had an inadequate defibrillator threshold safety margin.

Failure to Shock or Properly Shock Medical Device Problem

Issue associated with the inability of device and/or device components to provide an appropriate or successful electrical shock.

Failure to Separate Medical Device Problem

Issue associated with the device or one of its components failing to detach or separate as intended.

Failure to Sense Medical Device Problem

Issue associated with the failure of a device designed to respond to a physical stimulus (as temperature, illumination, motion) to transmit a…