Hazard Analysis

Rating	Criteria: Severity	Consequence	Treatment
8	Death	N/A	N/A
7	Cardiac Arrest	Permanent damage to the heart	Hospital Stay
6	High Level Burns	Third degree burn	Hospital
5	Low Level Burns	First degree burn	Hospital or ambulant treatment
4	Electric Shock	Electric Shock	Self Treatment
3	Minor Cuts	Discomfort	Self Treatment
2	Skin Irritation	Discomfot	N/A
1	No Harm	N/A	N/A

Rating	Criteria: Occurrence
8	Highly likely to occur during each use
7	Likely to occur during each use
6	Occurs every other use
5	Occurs every 1 out of 15 uses
4	Occurs every 1 out of 10 uses
3	Occurs every 1 out of 100 uses
2	Occurrence is very unlikely
1	Essentially never occuring

	S	e	v	e	r	i	t	y
		1	2	3	4	5	6	7	8
	8	R2	R2	R2	R2	R3	R3	R3	R3
	7	R1	R2	R2	R2	R2	R2	R3	R3
	6	R1	R1	R2	R2	R2	R2	R2	R3
Occurrence Level	5	R1	R1	R1	R2	R2	R2	R2	R3
	4	R1	R1	R1	R2	R2	R2	R2	R3
	3	R1	R1	R1	R1	R2	R2	R2	R3
	2	R1	R1	R1	R1	R1	R2	R2	R3
	1	R1	R1	R1	R1	R1	R1	R2	R3

Values are based off severity and occurrence tables shown above

R1 = Acceptable Risk

R2 = As Low as Reasonably Possible

R3 = Unacceptable

Hazard	Chain of Events	Hazardous Situation	Potential Harms	Severity	Probability	Risk	Mitigation
Electrical Hazard	*User treats the device in a harsh manner. *The circuit is exposed. *User touches the exposed circuit.	Patient gets shocked	Burning of skin	5	5	R2	N/A
Sharpened Device	*Device is damaged and part of device is sharpened *The patient cuts themselves on exposed sharp edge	Patient gets cut	Bleeding, infection	6	1	R1	N/A
Swallowing	*Patient leaves device unattended and is swallowed by an infant	Patient swallows device	Internal Damage	8	1	R3	Labelling on packaging to not swallow device