| Health / Medical Topics |
Device Environment Problem Evaluation Result
A device problem that occurred due to factors within the environment e.g. dust, dirt, humidity, temperature. (Food and Drug Administration)
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Device problems related to the energy storage system (e.g. the rechargeable battery, charging system, or capacitor) and includes problems such as premature…
The undesirable presence of toxins associated with certain bacteria (e.g. gram negative bacteria).
Device problems that occur from its reaching the end of its useful life.
Testing the device for adequately controlled electromagnetic emissions.
Movement of a medical device to an unintended location within the body with resulting obstruction of an organ or vessel.
Testing the device for malfunctions related to the transfer of an electrostatic charge (by direct contact or from electrostatic fields) between objects…
