CDRH Cause Investigation - Investigation Findings Terminology

Preferred Label : CDRH Cause Investigation - Investigation Findings Terminology;

NCIt synonyms : Annex C;

NCIt related terms : Cause Investigation - Investigation Findings;

NCIt definition : Terms/codes for describing the findings in the specific investigation that are the keys to identify the root cause used by the CDRH.;

Details

Origin ID

C91801;

UMLS CUI

C5421250;

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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- Alarm System Problem Identified [NCIt concept]
- Ambient Light Problem Identified [NCIt concept]
- Appropriate Term/Code Not Available Identified [NCIt concept]
- Artificial Intelligence Training/Validation Problem Identified [NCIt concept]
- Assembly Problem Identified [NCIt concept]
- Biocompatibility Problem Identified [NCIt concept]
- Biological Contamination [NCIt concept]
- Biological Problem Identified [NCIt concept]
- Blockage Identified [NCIt concept]
- Change in Target Marker/Variant/Mutant [NCIt concept]
- Clinical Imaging Problem Identified [NCIt concept]
- Communications Problem Identified [NCIt concept]
- Complement Activation Problem [NCIt concept]
- Conducted Interference [NCIt concept]
- Configuration Issue [NCIt concept]
- Contamination of Environment by Device [NCIt concept]
- Corrupt Software [NCIt concept]
- Corrupted Memory [NCIt concept]
- Current Leakage Problem [NCIt concept]
- Cytotoxicity Problem Identified [NCIt concept]
- Data Compression Error [NCIt concept]
- Data Storage or Loss of Data [NCIt concept]
- Deformation Problem [NCIt concept]
- Degradation Problem Identified [NCIt concept]
- Design Error [NCIt concept]
- Device Agglutination Problem [NCIt concept]
- Device Carcinogenic Problem [NCIt concept]
- Device Difficult to Operate [NCIt concept]
- Device Fatigue Problem [NCIt concept]
- Device Fracture Problem [NCIt concept]
- Device Friction Problem Identified [NCIt concept]
- Device Genotoxicity Problem Identified [NCIt concept]
- Device Hematologic Problem Identified [NCIt concept]
- Device Improper Composition/Concentration [NCIt concept]
- Device Incorrectly Assembled During Reprocessing [NCIt concept]
- Device Incorrectly Cleaned During Reprocessing [NCIt concept]
- Device Incorrectly Disinfected/Sterilized During Reprocessing [NCIt concept]
- Device Incorrectly Reprocessed [NCIt concept]
- Device Migration Problem Identified [NCIt concept]
- Device Misadjustment/Misalignment Identified [NCIt concept]
- Device Not Compatible With Another Device [NCIt concept]
- Dust or Dirt Problem Identified [NCIt concept]
- Electrical Problem Identified [NCIt concept]
- Electrical/Electronic Component Problem Identified [NCIt concept]
- Electromagnetic Compatibility Problem Identified [NCIt concept]
- Electrostatic Discharge Problem [NCIt concept]
- Endotoxin Contamination [NCIt concept]
- Energy Storage System Problem [NCIt concept]
- Environment Problem Identified [NCIt concept]
- Environmental Humidity Problem Identified [NCIt concept]
- Environmental Pressure Problem Identified [NCIt concept]
- Environmental Temperature Problem Identified [NCIt concept]
- Erroneous Data Transfer [NCIt concept]
- Excessive Cooling Identified [NCIt concept]
- Excessive Heating Identified [NCIt concept]
- Fail-safe Problem Identified [NCIt concept]
- Failure to Calibrate or Used Out of Calibration [NCIt concept]
- Gradient Induced Field Problem [NCIt concept]
- Hardware Timing Problem Identified [NCIt concept]
- Image Artifact [NCIt concept]
- Impedance Problem Identified [NCIt concept]
- Improper Physical Structure [NCIt concept]
- Inadequate Cooling Identified [NCIt concept]
- Inadequate Device Immunity [NCIt concept]
- Inadequate Labeling and/or Instructions for Use [NCIt concept]
- Inadequate Physicochemical Properties [NCIt concept]
- Inadequate or Incorrect Instructions for Maintenance [NCIt concept]
- Inappropriate Device Material [NCIt concept]
- Incompatible Component/Accessory [NCIt concept]
- Incompatible Material [NCIt concept]
- Incorrect Algorithm [NCIt concept]
- Incorrect Data Definition [NCIt concept]
- Incorrect Dimension [NCIt concept]
- Incorrect Interpretation of Results/Data [NCIt concept]
- Incorrect Labeling and/or Instructions for Use [NCIt concept]
- Installation Problem Identified [NCIt concept]
- Insufficient Sample Volume [NCIt concept]
- Insulation Problem Identified [NCIt concept]
- Interface Design Error [NCIt concept]
- Interoperability Problem Identified [NCIt concept]
- Known Interferent [NCIt concept]
- Labeling and Instructions for Use/Maintenance [NCIt concept]
- Leakage/Seal [NCIt concept]
- Light Source Problem Identified [NCIt concept]
- Loss of Power Identified [NCIt concept]
- Lubrication Problem Identified [NCIt concept]
- Magnetically Induced [NCIt concept]
- Maintenance Problem Identified [NCIt concept]
- Maintenance of Manufacturing Machinery [NCIt concept]
- Malfunction Observed Without Conclusive Finding [NCIt concept]
- Manufacturing Process Problem Identified [NCIt concept]
- Material and/or Chemistry Problem Identified [NCIt concept]
- Material or Material Leachate Pyrogenic Problem [NCIt concept]
- Mechanical Problem Identified [NCIt concept]
- Mechanical Shock Problem [NCIt concept]
- Microbial Contamination [NCIt concept]
- Missing or Inadequate Safety Measures Identified [NCIt concept]
- Molecular Structure Problem [NCIt concept]
- Mutagenic Problem [NCIt concept]
- Network Communication Problem [NCIt concept]
- New or Unknown Interferent [NCIt concept]
- No Device Problem Found [NCIt concept]
- No Findings Available [NCIt concept]
- Non-Functional Defect [NCIt concept]
- Open Circuit [NCIt concept]
- Operational Problem Identified [NCIt concept]
- Optical Problem Identified [NCIt concept]
- Optical Transmission Problem Identified [NCIt concept]
- Overheating Problem Identified [NCIt concept]
- Packaging Compromised [NCIt concept]
- Packaging Contains Incorrect or Incomplete Device [NCIt concept]
- Packaging Contains Unintended Material [NCIt concept]
- Packaging Materials Problem [NCIt concept]
- Packaging Problem Identified [NCIt concept]
- Patient Sample Problem [NCIt concept]
- Platelet Activation Problem [NCIt concept]
- Power Fluctuation [NCIt concept]
- Power Source Problem Identified [NCIt concept]
- Pre-analytical Handling Problem [NCIt concept]
- Premature Indicator Activation [NCIt concept]
- Problem due to Thrombosis Activation [NCIt concept]
- Problem of Device to Self-Test [NCIt concept]
- Problem to Auto Stop [NCIt concept]
- Protective System Problem Identified [NCIt concept]
- Radiofrequency Induced Overheating [NCIt concept]
- Radiofrequency Interference Identified [NCIt concept]
- Reactivity Problem Identified [NCIt concept]
- Reproductive Toxicity Problem Identified [NCIt concept]
- Reset Problem [NCIt concept]
- Results Pending Completion of Investigation [NCIt concept]
- Shielding Problem [NCIt concept]
- Short Circuit [NCIt concept]
- Signal Loss [NCIt concept]
- Software Installation Problem Identified [NCIt concept]
- Software Maintenance Problem Identified [NCIt concept]
- Software Problem Identified [NCIt concept]
- Software Requirement Error [NCIt concept]
- Software Runtime Error [NCIt concept]
- Software Security Vulnerability [NCIt concept]
- Software Timing Problem [NCIt concept]
- Sterilization Problem Identified [NCIt concept]
- Stiffness Problem Identified [NCIt concept]
- Storage Problem Identified [NCIt concept]
- Stress Problem Identified [NCIt concept]
- Thermal Problem [NCIt concept]
- Tolerance Stack-Up [NCIt concept]
- Transport Problem Identified [NCIt concept]
- Transport/Storage Problem Identified [NCIt concept]
- Undesirable Presence of Endogenous Materials [NCIt concept]
- Unintended Compatibility [NCIt concept]
- Unintended Emission [NCIt concept]
- Unintended Presence of Allergens [NCIt concept]
- Usage Problem Identified [NCIt concept]
- Use of Non-Validated Controls Identified [NCIt concept]
- Vibration Problem [NCIt concept]
- Wear Problem [NCIt concept]
- Wired Communication Problem [NCIt concept]
- Wireless Communication Problem Identified [NCIt concept]

Keyword's position in hierarchy(ies) :

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