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Medical device incidents are problems with any type of medical product or equipment that led to or could have led to a serious health concern. A medical device incident can occur shortly after beginning treatment or much later. Harm from a medical device can be mistaken for a symptom of a disease (PFPSC et al., n.d.).

Everyone who witnesses or experiences a problem with a medical device is strongly encouraged to report it. A patient or their care provider can also work with their healthcare provider to submit a report . Medical devices range from adhesive bandages, toothbrushes, and contact lenses to complex devices such as x-ray units, insulin pumps, and pacemakers. They also include in vitro diagnostic devices, such as cancer screening tests, blood glucose monitors, and pregnancy test kits (Health Canada, 2020).

Examples of Medical Device Incidents are:

  • An infusion pump stopped working and did not give an alarm. The patient needed a longer stay in hospital.
  • A defibrillator used to treat a cardiac arrest did not work properly. The patient was not revived. 
  • A prosthetic knee replacement failed due to damaged material.
  • A breast implant was suspected of causing a rare cancer.

Awareness and conversation with health care providers are key components in identifying a serious adverse drug reaction or medical device incident (PFPSC et al., n.d.).

Patient Story – CPSI-PFPSC

If something doesn't feel right, you have to ask the question

Two weeks after his brush with death, Nicholas Bravi stepped out of his shower with the steri-strips washed away and the angry red scar on his chest fully visible for the first time (CPSI, 2014).