Medical Device Electronic Property Issue

Issue associated with any deviations from device documented performance specifications relating to devices, circuits, or systems utilizing electrons and in association with components to convert, control and condition of electric power (alternating or direct current), and of voltage and current. (Food and Drug Administration)

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Medical Device Electrical Issue

Issue associated with a failure of the electrical circuitry or components of the device.

Medical Device Difficult to Prepare

Issue associated with the use of the device in terms of user experiencing difficulty in preparing the device for use, even if…

Medical Device Deployment Issue

Issue associated with any deviations from device documented performance specifications relating to the sequence of events for activation and positioning of the…

Medical Device Deployment

The act of instantiating, positioning or activating a medical device inside of the body.

Medical Device Delivered As Unsterile Product

Issue associated with the device being received in such a manner to indicate that its sterility has been compromised (e.g. sterile packaging…

Medical Device Contamination during Use

Issue associated with the undesired introduction of impurities either chemical or microbiological in nature, or of foreign matter into or onto the…