C54029Level 6

Device Evaluation Result

**Semantic type:** Functional Concept

**Definition:** The result of a device evaluation.

**Synonyms:** - EVALUATION RESULT

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C139466Appropriate Investigation Findings Term/Code Not Available

C139467Patient Sample Problem

C139468Transport/Storage Problem Identified

C139483Cytotoxicity Problem Identified

C139484Unintended Presence of Allergens

C139485Device Incorrectly Assembled During Reprocessing

C139486Device Incorrectly Cleaned During Reprocessing

C139487Device Incorrectly Disinfected/Sterilized During Reprocessing

C139488Network Communication Problem

C139489Electrical/Electronic Component Problem Identified

C139490Unintended Emission

C139491Ambient Light Problem Identified

C139493Environmental Pressure Problem Identified

C139494Device Not Compatible With Another Device

C139495Unintended Compatibility Identified

C139496Inadequate or Incorrect Instructions for Maintenance

C139497Maintenance of Manufacturing Machinery

C139498Inadequate Physicochemical Properties

C139499Incorrect Dimension

C139500Leakage/Seal

C139501Incorrect Interpretation of Results/Data

C139502Light Source Problem Identified

C139503Packaging Contains Incorrect or Incomplete Device

C139504Packaging Contains Unintended Material

C139505Packaging Materials Problem

C139506Alarm System Problem Identified

C139507Fail-safe Problem Identified

C139508Missing or Inadequate Safety Measures Identified

C139509Premature Indicator Activation Identified

C139510Problem of Device to Self-Test

C139511Problem to Auto Stop

C139512Reset Problem Identified

C139513Shielding Problem

C139514Data Storage or Loss of Data

C139515Erroneous Data Transfer

C139516Software Maintenance Problem Identified

C139517Excessive Cooling Identified

C139518Excessive Heating Identified

C139519Inadequate Cooling Identified

C139520Overheating Problem Identified

C139521Device Problem Related to Variant/Mutant

C139522Known Interferent

C139523New or Unknown Interferent

C139524Pre-analytical Handling Problem

C139575Device Incorrectly Reprocessed

C139576Sterilization Problem Identified

C171993Inadequate Device Lubrication

C177431Inadequate Cybersecurity

C177433Inadequate Software Design

C177435Cause Linked to Device but Unable to Trace More Specifically

C177436Cause Traced to Software Coding

C187263Artificial Intelligence Training/Validation Problem Identified

C187264Corrupt Software

C187266Cause Traced to Artificial Intelligence Training/Validation Process

C193383Corrupted Memory

C193387Cause Traced to Another Device

C193388Cause Traced to Health Disparity

C91870Device Difficult to Operate

C92026Device Agglutination Problem

C92027Device Arithmetic Error Evaluation Result

C92028Assembly Problem Identified

C92029Biocompatibility Problem Identified

C92030Biological Problem Identified

C92031Device Carcinogenic Problem

C92032Device Chemical Agent Damage Evaluation Result

C92033Device Cleaning Disinfecting Sterilization Problem Evaluation Result

C92034Communications Problem Identified

C92035Complement Activation Problem

C92036Device Migration Problem Identified

C92037Conducted Interference

C92038Configuration Issue

C92039Data Compression Error

C92040Deformation/Distortion Problem

C92041Degradation Problem Identified

C92042Design Error

C92043Contamination of Device by Foreign Material from Environment

C92044Current Leakage Problem

C92045Electrical Problem Identified

C92046Electromagnetic Compatibility Problem Identified

C92047Electrostatic Discharge Identified

C92049Endotoxin Contamination

C92050Energy Storage System Problem

C92051Environment Problem Identified

C92052Failure to Calibrate or Used Out of Calibration

C92053Device Fatigue Problem

C92055Device Separation Problem

C92056Device Friction Problem Identified

C92057Device Genotoxicity Problem Identified

C92058Gradient Induced Field Problem

C92059Hardware Timing Problem Identified

C92060Device Hematologic Problem Identified

C92061Environmental Humidity Problem Identified

C92062Image Artifact

C92063Impedance Problem Identified

C92064Device Improper Composition/Concentration

C92065Inappropriate Device Material

C92066Incompatible Component/Accessory

C92067Installation Problem Identified

C92068Insulation Problem Identified

C92069Interface Design Error

C92070Interoperability Problem Identified

C92071Labeling and Instructions for Use/Maintenance

C92072Loss of Power Identified

C92073Lubrication Problem Identified

C92074Magnetically Induced

C92075Maintenance Problem Identified

C92076Manufacturing Process Problem Identified

C92077Material or Material Leachate Pyrogenic Problem

C92078Material and/or Chemistry Problem Identified

C92079Mechanical Problem Identified

C92080Mechanical Shock Problem

C92081Microbial Contamination

C92082Mutagenic Problem

C92083No Device Problem Found

C92084No Findings Available

C92085Non-Functional Defect

C92086Device Non-Terminating Software Code Evaluation Result

C92087Open Circuit

C92088Operational Problem Identified

C92089Optical Problem Identified

C92090Optical Transmission Problem Identified

C92091Device Out of Bounds Error Evaluation Result

C92092Device Package Insert Problem Evaluation Result

C92093Packaging Compromised

C92094Packaging Problem Identified

C92095Platelet Activation Problem

C92096Power Fluctuation

C92097Power Source Problem Identified

C92098Protective System Problem Identified

C92100Radiofrequency Induced Overheating

C92101Radiofrequency Interference Identified

C92102Clinical Imaging Problem Identified

C92103Reactivity Problem Identified

C92104Reproductive Toxicity Problem Identified

C92105Device Runtime Memory Access Error Evaluation Result

C92107Transport Problem Identified

C92108Short Circuit

C92109Signal Loss

C92110Device Software Deadlock Evaluation Result

C92111Software Installation Problem Identified

C92112Device Software Livelock Evaluation Result

C92113Software Problem Identified

C92114Software Requirement Error

C92115Software Runtime Error

C92116Software Security Vulnerability

C92117Software Timing Problem

C92118Stiffness Problem Identified

C92119Storage Problem Identified

C92120Stress Problem Identified

C92121Molecular Structure Problem

C92122Thermal Problem

C92123Problem due to Thrombosis Activation

C92124Tolerance Stack-Up

C92125Device Type Mismatch Evaluation Result

C92126Device Unhandled Interrupt or Exception Evaluation Result

C92127Device Unreachable Code Evaluation Result

C92128Device Unused Device Returned in Sterile Packaging Evaluation Result

C92129Vibration Problem

C92130Wear Problem

C92131Wired Communication Problem

C92132Wireless Communication Problem Identified

C92133Improper Physical Structure

C92134Environmental Temperature Problem Identified

C92135Inadequate Device Immunity

C92136Incorrect Labeling and/or Instructions for Use

C92137Inadequate Labeling and/or Instructions for Use

C92138Inappropriate or Insufficient Device Sterilization Evaluation Result

C92139Incompatible Material

C92140Incomplete Device Returned Evaluation Result

C92141Incorrect Data Definition

C92142Incorrect Algorithm

C92143Results Pending Completion of Investigation

C92144Reused Device not Cleaned Evaluation Result

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