Inadequate Medical Device Cleaning

Issue associated with the insufficient removal of unwanted visible soil, foreign material or organism deposits on the external surfaces, crevices, joints of a device by a mechanical and/or manual process intended to render the device sterile, safe for handling, and/or for further processes to decontaminate. (Food and Drug Administration)

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Inadequate Instructions for Device Use Evaluation Result

Insufficient information on the labels or in the manuals related to a device's instructions for use e.g. steps that are difficult to…

Inadequate Device Operator Training

Issue associate with facility not providing satisfactory initial and/or periodic user training covering operation of the device.

Inadequate Device Labeling Content Problem Evaluation Result

Invalid, incorrect, or inappropriate information on the labels (not including instructions for use) e.g. mislabeled contents or device labeling characteristics or package…

Inadequate Device Immunity Problem Evaluation Result

A device that lacks adequate immunity or capabilities to resist electromagnetic interference (EMI).

Inadequate Application Program User Interface Associated with Medical Device Problem

Issue associated with the means by which the operator and the equipment communicate or interact.

Inadequate

Not meeting a quantitative or qualitative measure necessary for a requirement.