| Table XII-1. | |||||
| Hazard | Cause/Failure Mode | Severity | Probability | Risk Level | Method of Risk Reduction/Mitigation |
| 1. Skin irritation and allergic reactions. | 1. Use of low-quality or incompatible materials. | 3 | 2 | 6 | 1. Use tested biocompatible materials and washable cushions. |
| 2. Device malfunction. | 2. Hardware or software failure. | 1 | 3 | 3 | 2. Conduct thorough quality control testing. |
| 3. Incorrect readings. | 3. Improper calibration or usage. | 1 | 2 | 2 | 3. Regular calibration and user training. |
| 4. Sensor damage. | 4. Mishandling or wear and tear. | 2 | 2 | 4 | 4. Design the device to be sturdy and durable. |
| 5. Discomfort or pain. | 5. Poor fit or prolonged wear. | 2 | 3 | 6 | 5. Design the device to be lightweight and comfortable. |
Designsafe analysis of the product.
Rating of severity and probability are based on a 1-5 scale with 1 being very low and 5 standing for very high. The risk level is the product of severity and probability. The Risk level definition is shown as follows:
Table XII-2. Risk level definition
Risk level >11 is considered as: need for mitigation.
Risk level >5 but <=11 is considered as: acceptable, but could be better.
Risk level <=5 is considered as: acceptable.