Device Installation Problem Evaluation Result

A device that malfunctions because it was incorrectly installed, set-up, or configured (e.g., misconfiguration of an automatic defibrillator to semi-automatic leading to failure) (Food and Drug Administration)

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Device Ingress Protection Testing Evaluation Method

Testing the device's ability to protect against ingress or access of unwanted fluids or solids.

Device Ingredient or Reagent Device Component

A consumable material that is added to a device and is used to make a finished product or becomes part of a…

Device Infrastructure Failure Evaluation Conclusion

Device problems related to problems with the underlying framework, systems, and processes of an organization (e.g. as building power supply, network, oxygen…

Device Incorrectly Prepared for Use or Modified Evaluation Conclusion

A device that is incorrectly modified or prepared for use by distributor, service provider, or user facility.

Device Incompatible Component Evaluation Result

A device that malfunctions due to a component(s) that does not operate correctly and according to the device's specifications.

Device In Situ Observation Evaluation Method

Observing the device in the exact same conditions and setting in which the device was used.