Inadequate Storage of Medical Device

Pacing voltage or pulse width is less than desired.

Issue associated with inadequate periodic preventive maintenance or performance assurance checks.

Issue associated with the insufficient removal of unwanted visible soil, foreign material or organism deposits on the external surfaces, crevices, joints of…

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

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

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