Health / Medical Topics

    Device Thrombosis Activation Problem Evaluation Result

    The device or component caused the formation of a stationary blood clot along the walls of a blood vessel resulting in an obstruction. The obstruction can occur by several means e.g. blood clotting problems (coagulation), clots from other areas of the body (emboli), or caused by device materials or reactions to drugs or the removal of drugs. (Food and Drug Administration)




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    Device problems related to the temperature of the component, device or use environment.
    Testing the device for conditions related to extremes of temperature.
    Testing the device's characteristics when subjected to temperature change (cycling), and high or low temperatures.
    Tests conducted on a complete, integrated system to evaluate the system's compliance with its specified requirements.
    Testing for a response to a transient electrical current or voltage.
    Testing the device's ability to protect itself of other devices against sudden bursts of current or voltage.

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