Below are detailed descriptions of reportable adverse events, grouped by state or federal agency. Answer the question that appears beneath EACH description. When you're finished, click View Reporting Instructions to move to the next page.
Incident that results in injury to a patient, not ordinarily expected as a result of the patient’s condition.
Examples include, but are not limited to:
In this context, DPH defines an injury as “harm that results in exacerbation, complication or other deterioration of a patient’s condition.”
Reference: 105 CMR § 170.350
A motor vehicle crash involving an EMS vehicle resulting in personal injury, death, or property damage above $1,000.00.
If the crash resulted in personal injury or death to a patient, make sure that you have clicked “yes” to the “Serious Incident" question, above.
References: 105 CMR § 170.350(A); M.G.L. c. 90, § 26.
A “service’s place of business” is the place of business of either an emergency first response (EFR) service or ambulance service, including headquarters, branch offices, garages, etc.
References: 105 CMR §§ 170.350(A), 170.020
Death or serious injury of a patient associated with a medical device.
This reporting obligation applies to “device user facilities,” which include ambulance providers and rescue services.
The incident is reportable if a device user facility becomes aware of information that reasonably suggests that a device has or may have caused or contributed to the death or serious injury of your patient. This includes instances when the medical device may have merely been a factor in the death or serious injury, including, but not limited to instances of:
In this context, "serious injury" is an injury or illness that:
Note that the FDA’s definition of medical device is fairly broad and includes simple instruments. For more information about FDA regulations on adverse events reporting please visit FDA Mandatory Reporting Requirements.
References: 21 CFR §§ 803.3, 803.30.
