Severity Table

Score	Definition	Consequence
4	Critical	Burns – Reversible Injury
3	Serious	Severe Irritation – Reversible Injury
2	Minor	Minor Irritation – Discomfort
1	Negligible	No Harm

Occurrence Table 

Score	Definition	Description
4	Frequent	Happens often
3	Probable	Likely to happen
2	Occasional	Can happen
1	Improbable	Unlikely to happen

RPN Table

		Severity Levels
		Negligible	Minor	Serious	Critical
Occurrence Levels	Frequent	R2	R2	R3	R3
	Probable	R2	R2	R2	R3
	Occasional	R1	R1	R2	R2
	Improbable	R1	R1	R2	R2

RPN = Occurrence + Severity

R1: 2 ≤ RPN ≤ 4

R2: 5 ≤ RPN ≤ 6

R3: 7 ≤ RPN ≤ 8

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Hazard Analysis Table

Hazard	Hazard Event	Harm	Severity	Occurrence	Total Risk	Root Cause
Adhesion Sticks to the Patient	* The adhesion slips from its spot on the patient’s diaper * Incorrect placement by caretaker	Skin Irritation	Minor (2)	Occasional (2)	R1 (4)	Device Misuse
Improper Cleaning	User does not follow directions and incorrectly carries out the cleaning sequence	* Increased Risk of Infection * Compromised Urine Sample	Minor (2)	Occasional (2)	R1 (4)	Device Misuse
Exposed Wall Plug	Liquid spillage on electrical components due to user error or mishandling	Electric Shock	Serious (3)	Improbable (1)	R1 (4)	Device Misuse
Sensor Malfunction	Temperature sensor fails to detect urination cycle	* Leakage* Spoiled Clothing/Bedding * Skin Irritation	Minor (2)	Improbable (1)	R1 (3)	* Faulty Sensor* Electronic Failure
Tubing Blockage or Detachment	Tubing detaches or becomes clogged	* Sample Overflow/ Backflow * Leakage* Skin Irritation	Minor(2)	Occasional (2)	R1 (4)	* Kinking* Improper Assembly* Material Defect
Color Sensor Inaccuracy	Color sensor misreads urine sample	* Misdiagnosis* Increased Risk of Infection	Serious (3)	Improbable (1)	R1 (4)	* Calibration Error * Sensor Contamination