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Guidelines for Reporting a Medical Device Incident

Medical Devices Between Fail-safe and Safe-life

The saying “Necessity is the mother of invention” is by far the most applicable maxim in the world of Medical Technology. A pointer to this is the recent collaboration between Ford (a renowned automobile manufacture) and GE healthcare to mass produce respirators and ventilators in response to Covid-19 pandemic.

The result of all these is a possible unplanned downtime in the life-cycle of the respirators. Worse still, faulty device resulting from rushed production could lead straight to the same death a patient seeks to escape in Covid-19. It is for this reason that all healthcare professionals are required to master the art of medical device incident reporting as a panacea to fail-safe manufacturing.

A Medical device is any instrument, software, material or other similar article, intended by the manufacturer to be used, alone or in combination, for human beings, for specific medical purposes, including diagnosis, prevention, monitoring, treatment of disease, injury etc (TGA).

An adverse event on the other hand, is an event that led to death, life-threatening illness or injury, or permanent impairment or damage to the body. A close call is an adverse event that due to the timely intervention of a healthcare practitioner, a death or serious injury was averted.

Determining an effective Medical Device Incident Reporting system takes into consideration all the plausible causes of adverse incident with Medical Devices including one or a combination of mechanical failure, manufacturing errors, device interaction, software deficiencies and user error.

Requirements for Reporting a Device Incident

Three classes of people are saddled with the responsibility of reporting a medical device adverse incident. They are:

  • Consumer: Patient or healthcare practitioner that reports to the healthcare facility.
  • Device professional: Biomedical Engineer acting in capacity of a healthcare facility or distributor.
  • Manufacturer: Device manufacturer reports to the appropriate regulatory body, determined either by the country of use or country of manufacture.

In this blog post, we will be addressing Medical Device Incident Reporting from the perspective of a Device professional. See the below table for a breakdown.

The hospital monitors and reports all incidents in which medical equipment is suspected in or attributed to the death, serious injury, or serious illness of any individual.

SMDA (1990) – EC.02.04.01




User Facility Device-related Death Form FDA 3500A FDA & Manufacturer Within 10 work days of becoming aware
User Facility Device-related Serious injury Form FDA 3500A Manufacturer. FDA only if manufacturer is unknown Within 10 work days of becoming aware
User Facility Annual summary of death & serious injury reports Form FDA 3419 FDA January 1 for the preceding year

The Biomedical Engineer upon receiving a report from the consumer, correlates the device incident with its presumed underlying cause. This will be a lot more informative if you could lay your hand on a video record of the event and use it to determine the rate of occurrence.

You should follow it up with investigatory procedures such as impounding the device, preserving error codes and control settings, conducting interviews with attending personnel at the time of the event, assessing any injury or damage, and thereafter file a detailed report with the regulatory body.

Categories of Medical Device Incident Report

Mandatory report

Mandatory report requires that a manufacturer, device user facilities, or importer submits report of medical devices related death to the regulatory body.

Voluntary report

Voluntary report encourages health care professionals, patients, caregivers and consumers to submit reports about serious adverse events that may be associated with a medical device, as well as use errors, product quality issues, and therapeutic failures.

Sample form for Medical Device Incident Reporting



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