CDRH Cause Investigation - Investigation Conclusion Terminology

Preferred Label : CDRH Cause Investigation - Investigation Conclusion Terminology;

NCIt synonyms : Annex D;

NCIt related terms : Cause Investigation - Investigation Conclusion;

NCIt definition : Terms/codes for describing the conclusion of the device involved in the reported event used by the CDRH.;

Details

Origin ID

C91802;

UMLS CUI

C5421251;

Semantic type(s)
- Intellectual Product [UMLS semantic type]
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- FDA Center For Devices and Radiological Health Terminology [NCIt concept]
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- Adverse Event Related to Commutability [NCIt concept]
- Adverse Event Related to Patient Condition [NCIt concept]
- Adverse Event Related to Procedure [NCIt concept]
- Appropriate Term/Code Not Available Problem [NCIt concept]
- Cause Linked to Device but Unable to Trace More Specifically [NCIt concept]
- Cause Not Established [NCIt concept]
- Cause Traced to Another Device [NCIt concept]
- Cause Traced to Artificial Intelligence Training/Validation Process [NCIt concept]
- Cause Traced to Component Failure [NCIt concept]
- Cause Traced to Device Design [NCIt concept]
- Cause Traced to Environment [NCIt concept]
- Cause Traced to Health Disparity [NCIt concept]
- Cause Traced to Infrastructure [NCIt concept]
- Cause Traced to Intentional Off-Label, Unapproved, or Contraindicated Use [NCIt concept]
- Cause Traced to Labeling [NCIt concept]
- Cause Traced to Maintenance [NCIt concept]
- Cause Traced to Manufacturing [NCIt concept]
- Cause Traced to Non-Device Related Factors [NCIt concept]
- Cause Traced to Software Coding [NCIt concept]
- Cause Traced to Training [NCIt concept]
- Cause Traced to Transport/Storage [NCIt concept]
- Cause Traced to User [NCIt concept]
- Conclusion not Yet Available [NCIt concept]
- Design Change Validation Inadequate [NCIt concept]
- Design Inadequate for Purpose [NCIt concept]
- Device Problem Excluded [NCIt concept]
- End of Life Problem Identified [NCIt concept]
- Failure to Follow Instructions [NCIt concept]
- Falsified Device [NCIt concept]
- Human Factors Engineering - Device Difficult to Assemble [NCIt concept]
- Human Factors Engineering - Device Difficult to Operate [NCIt concept]
- Human Factors Engineering - Device Difficult to Reprocess [NCIt concept]
- Inadequate Cybersecurity [NCIt concept]
- Inadequate Software Design [NCIt concept]
- Known Inherent Risk of Device [NCIt concept]
- Manufacturing Deficiency [NCIt concept]
- Missing or Inadequate Safety Measures Problem [NCIt concept]
- No Problem Detected [NCIt concept]
- Quality Control Deficiency [NCIt concept]
- Reasonably Foreseeable Misuse [NCIt concept]
- Reuse of Single Use Device [NCIt concept]
- Sabotage or Intentional Misuse [NCIt concept]
- Shelf Life/Expiration Date Exceeded [NCIt concept]
- Unable to Exclude Device Problem [NCIt concept]
- Unintended Use Error Caused or Contributed to Event [NCIt concept]

Keyword's position in hierarchy(ies) :

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