Hazard Analysis

1) Severity table used for risk assessment – with score definitions 

Severity Table

RatingSeverity of EffectFuture consequencesTreatment
10Death
9Cardiac ArrestCardiac Tissue DamageUse a Defibrillator  
8ArthymeaUnstable Heart RateReset heart rhythm
7Pulmonary EmbolismLung cell deathLung surgery
6Severe Skin BurnsPermanent tissue damage, scarringBurn treatment, and surgeries
5DVT FormationVessel DamageAnticoagulant medication 
4Mild Skin BurnsTissue Damage, ScarringBurn treatment, 
3Skin Burns from electric shocksTissue damageHeals over time.
2Severe Skin IrritationLong Lasting DiscomfortRemove Irritant, Cortical Lotion  
1Mild Skin IrritationMild Discomfort Remove Irritant

2) Occurrence table used for risk assessment – with score definitions 

RatingProbability of Occurrence
10Happening every use
9Happening every other user
81 in 5
71 in 10
61 in 50
51 in 100
41 in 500
31 in 1000
21 in 5000
1Inconceivable

3) RPN table used for risk classification 

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4) Hazard and risk assessment spreadsheet – with score justifications 

HazardChain of EventsHazardous situationPotential HarmsSeverityProbabilityRisk
Battery ExplosionOvertaxed power supply, Overheated Battery, failure of battery controller. Batteries get wetBattery incineration Skin burnsSerious  (6)Improbable(1) R2
Electric shock




Circuit malfunction, Circuits get wet, Physical damage to device creates open circuit.Electric shockSkin burnsMinor(3)Improbable(1)R1
Skin irritationLED lights react to skin, camera reacts to skin, rough material to the skinReaction between the skin and some parts of the deviceReddening and inflammation, which Skew the resultsNegligible (1)Occasional (6)R2
Wrong data collection – O2 levelsDevice disconnects from Oximiter.Low O2 stats present without detectionDVT Formation, Pulmonary Embolism, Vessel DamageCritical (7)Improbable(1)R2
Wrong data collection – inflammation levelsDevice Dysfunction inflammationInflammation without detectionDVT Formation, Pulmonary Embolism, Vessel DamageCritical(7)Improbable (1)R2
LED BurnsArduino malfunctions increase the time of LED light exposure High temperatureDamages skinNegligible (1)Improbable (1)R1
Cut blood circulationDevice is too tight, device is too small for the user to useReduction in blood circulating to lower extremitiesIncrease vessel damage and clottingCritical (7)Remote(3)R2

5) Mitigation, as needed

HazardMitigation technique
Battery ExplosionMicrocontroller that checks voltage overshoot and shuts off power. 
Electric shockGround the device, Protect the device circuits from water
Skin irritationInstruct medical practitioners to check with patients for any discomfort regularly. 
LED BurnsThe frequency of what we measure will depend on the time the LED takes to cool down to room temperature.
Cut blood circulationInstruct medical practitioners on proper technique to tighten and secure device fittings.