Risk Assessment Form

Group Name: Biofeedback Device

Item User Task

1a All Users Handle the device
1b All Users Handle the device
2a Patient Place finger in device
2b Patient Place finger in device
2c Patient Place finger in device
2d Patient Move finger within device
2e Patient Callibrate each sensor
2f Patient Callibrate each sensor
3a Occupation Therapist Callibrate each sensor
3b Occupation Therapist Assist patient with finger placement
4a Technician Troubleshoot
Members:
Chris Zhang
Galen Cheng
Olivia Williams

Hazard
Electrical
Heat/Temperature
Environmental/Industrial Hygene
Electrical
Material Handling
Material Handling
Eronomic/Human Factors
Eronomic/Human Factors
Eronomic/Human Factors
Material Handling
Electrical
 Severity Exposure
Catastrophic Frequent
Serious Occasional
Slight Remote
Minimal None

Cause/Failure Mode Severity Exposure

Moisture from hands or other object short circuits device Serious Remote
Circuit overheats Serious Remote
Residue on finger prevents proper sensor utilization Slight Remote
Moisture from hands or other object short circuits device Serious Remote
Sensor detaches from moment arms Serious Remote
Overuse/overextension of device leads to diminished accuracy in sensor readin Slight Remote
Cannot see distinguish messages on LED display Minimal None
Cannot press buttons on interface because of small surface area Minimal None
Doesn't notice the miscalibration of the sensors Slight None
Tightens device too tightly to the discomfort of the patient Minimal None
Over time, wires get crossed Serious None
Probablity
Probable
Possible
Unlikely
Negligible

Probability Risk Level Method of Risk Reduction/Mitigation

Unlikely Medium m
Unlikely Medium Inform users in the manual to be cautious of circuit overheating
Unlikely Low With user manual, remind patients to make sure hands are clean
Unlikely Medium With user manual, remind patients to make sure hands are dry
Unlikely Low Reinforce weaker areas near the attachment pieces
Possible Medium Create interchangable backup attachments in case one scaffold fails
Possible Low Remind patient to use device in well lit area
Possible Low Remind patient to use properly working hand to utilize device
Possible Low Remind therapist to closely monitor patient utilization of device
Possible Low Inform therapist to check-in with patient to assess comfort levels
Unlikely Low In users manual, suggest having electric tape on hand to prevent cros
Severity Exposure Probability Risk Level Person Responsible Date
Minimal Remote Negligible Low Olivia Williams
Minimal Remote Negligible Low Olivia Williams
Minimal Remote Negligible Low Olivia Williams
Minimal Remote Negligible Low Chris Zhang
Slight Remote Unlikely Medium Galen Cheng
Minimal Remote Negligible Low Galen Cheng
Minimal None Negligible Low Chris Zhang
Minimal None Negligible Low Chris Zhang
Minimal None Negligible Low Chris Zhang
Minimal None Negligible Low Olivia Williams
Minimal None Unlikely Medium Chris Zhang
Comments
Severity Exposure Probability Risk Users
Catastrophic Frequent Probable High All Users
Serious Occasional Possible Medium Doctor
Slight Remote Unlikely Low Fabricator
Minimal None Negligible Family
Housekeeping
Nurse
Nurse Aide
Occupation Therapist
Paramedic
Patient
Public
Service Technician
Technician
Hazard Category Hazard
Biological/Health
Chemicals/Gases
Electrical
Environmental/Industrial Hygene
Eronomic/Human Factors
Fire/Explosion
Fluid Pressure
Heat/Temperature
Ingress/Egress
Laser
Material Handling
Mechanical
Noise/Vibration
Radiation
Slip/Trip/Fall
Ventilation/Confined Space
Wastes