Device Problem

Preferred Label : Device Problem;

NCIt synonyms : Device Issue; Medical Device Issue; Medical Device Problem;

NCIt related terms : MD PC; Medical Device Product Complaint;

NCIt definition : Medical device failure or malfunction associated with device functions, including any deviations from documented specifications, requirements, and intended uses.;

Alternative definition : ICH: Any concern about the safety, quality, and/or performance of a trial-related drug-device combination.;

NCI Metathesaurus CUI : CL554680;

Codes from synonyms : ICH M11-Trial-Related Safety Event Type;

Details

Origin ID

C54026;

UMLS CUI

C1537236;

Automatic exact mappings (from CISMeF team)
- Device issue [MedDRA Preferred Term]
- Device issues [MedDRA High Level Group Term]
Semantic type(s)
- Finding [UMLS semantic type]
concept_is_in_subset
- FDA Individual Case Safety Report Terminology [NCIt concept]
- ICH M11 Terminology [NCIt concept]
- ICH M11 Trial-Related Safety Event Type Value Set Terminology [NCIt concept]
- International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use Terminology [NCIt concept]

Keyword's position in hierarchy(ies) :

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