" /> Medical Device Operational Issue - CISMeF





Preferred Label : Medical Device Operational Issue;

NCIt related terms : Device Operational Malfunction; DEVICE OPERATIONAL ISSUE;

Alternative definition : CDISC: Issue associated with any deviations from specifications relating to device operations (e.g. deployment, connection, electrical, computer software, infusion/flow, output, protective-measure, and incompatibility issues).;

NCIt note : Deprecated by FDA CDRH June 2017;

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08/07/2025


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