FDA Center For Devices and Radiological Health Terminology Device Component Code Hierarchy Absorber Absorber (CO2) Sound Absorber Accumulator Actuator Adapter (Adaptor) Socket Adaptor Adhesive Air Cleaner Air Eliminator Air Pump Assembly Alarm Alarm, Assembly Alarm, Audible Alarm, LED Alarm, Power Alarm, Pressure Alarm, High Inspiratory Pressure Alarm, Low Inspiratory Pressure Alarm, Oxygen Pressure Alarm, Self Alarm, Visual Alarm, Volume Alternator Amplifier Analyzer Annunciator Antenna Applicator Arrester Attenuator Backpanel Backplane Baffle Bags Ball Ballast Balloon Barrier Battery Lithium Iodide Battery Beam Splitter Bearings Lower Piston Bearing Bed, Assist Bar Bell Belt Blower Bobbin Bolt Bottom Dead Center Sensor Bracket Brake Breathing Circuit Brush Bus Bushing Buzzer Cable Cutter-Torque Cable Optical Cable Calibrator Camera Cannula Cannula, Inner Cannula, Outer Cap Capacitor Shock Capacitor Carrier Cascade Cassette Caster Catheter Cautery Cell Charger Battery Charger Chassis Choke Circuit Board Circuit Breaker Clamp Clip Clock CO2 Monitor Subassembly (Only Use When Part Of Another Device) Coder Coil Conductor Coil Helifix Coil Tip Conductor Coil Collimator Comparator Computer Hardware CPU (Central Processing Unit Of Computer System) CPU (Central Processing Unit) Board Concentrator Connecting Rod Connector T-Piece Connector Y-Piece Connector Controller Converter Cord Power Cord Core Counter Counterbalance Coupler Cover Crank Arm Assembly Crystal Cuff Cups Current Limiter Current Source Cusp Cutter Cylinder Damper Decoder Defibrillator Paddles Dehumidifier Dehydrator Deionizer Delay Line Demagnetizer Demodulator Detector Bubble Detector Motion Detector Photodetector Device Deployer Device Ingredient Or Reagent Concentrate Device Subassembly Defibrillator Subassembly (Only Use When Part Of Another Device) EKG/ECG Subassembly (Only Use When Part Of Another Device) O2 Monitor Subassembly (Only Use When Part Of Another Device) Dial Diaphragm Digitizer Diode LED (Light Emitting Diode) Discrete Component/Device (Resistor, Capacitor, Diode) Disk Optical Disk Display Divider Dome Doubler Driver Duct Dummy Load Duplexer Electrode Electrode Contact Emergency Stop Button Or Switch Emergency Table Stop Emitter Enclosure Encoder Endoscope Endoscopic Accessory Equalizer Evaporator Expander Extender Extractor Eyelet Fan Fastener Feedthru Ferrule FET (Field Effect Transistor) Fiber Hollow Fiber Optical Fiber Fiberoptic External Fiberoptic Fiberoptic Cladding Fiberoptic Cleaver Film Film Cartridge Filter Bacterial Filter Exhalation Filter Sediment Filter Wedge Filter Flange Flasher Foil Foot Pedal Frame Function Lid Furnace Fuse Gas Scavenging Gasket Gauges/Meters Altimeter Bolometer Densitometer Flowmeter Magnetometer Oximeter (Only Use When Part Of Another Device) Potentiometer Pyrometer Scintillometer Spectrometer Spirometer Tachometer Thermometer Voltmeter Gears Generator Grille Grommet Ground Strap Guide Cannula Guide Fiberguide Piston Guides Waveguide Hand Immobilizer Handpiece Handrest Handset Haptic Header Headphone Heads Piston Heads Screw Head Headset Heart Valve Cage Heat Exchanger Heat Sink Heater Heater Rod Hinge Holder Hose Hose Line Housing Hub Humidifier Hybrid Circuit IC (Integrated Circuit) IC (Integrated Circuit) Chip Igniter Imager Impedance Converter Indexer Indicator Function Indicator Function Indicator Light Inductor Insulation Integrator Intercom Interconnection Board Intubate Interface User Interface Interrupter Intravenous Pole Inverter Isolator Jack Jaw Joint Joystick Jumper Junction Keyboard Keyer Keypad Kit Knife Knob Label Laminate Lamp Laser Latch Lead Electrical Lead Lead Conductor Leaflet Heart Valve Leaflet Leaflet Disk Lenses Contact Lens IOL (Intraocular Lens) Implant Limiter Line Conditioner Load Lock Locking Sleeve Logic Board Magazine Magnet Magnetizer Magnetoresistor Magnifier Manifold Matrices Mechanism Bolus Mechanism Locking Mechanism Lockout Mechanism Spring Loading Mechanism Membrane Memory RAM (Random Access Memory) ROM (Read Only Memory) PROM (Programmable Read Only Memory) EPROM (Erasable Programmable Read Only Memory) Microcircuit Microphone Microscope Mirror Mixer Modem Modulator Monitor CO2 Monitor EKG/ECG Monitor Motherboard Motor Stepper Motor Mount Multiplier Nebulizer (Only Use When Part Of Another Device) Needle Meter Needle Network None Nozzle Laser Nozzle Nuts Obturator Optocoupler Oscillator Oscilloscope Outlet Oven Overlay Oxygen Analyzer Pad Pallet Tomographic Pallet Panel PC (Printed Circuit) Board Photomultiplier Phototransistor Pickup Pin Connector Pin Motor Roll Pin Retaining Pin Pipette Piston Pads Pivot Plate Plotter Plug Plunger Pointer Polarizer Port Post Power Lamp Power Module Power Supply Preamplifier Prescaler Preselector Pressure Signal Printer Probe Probe, Transducer Pressure Sensor O2 Sensor Pressure Sensor Rate Modulated Pacing Sensor Temperature Sensor Temperature Probe Processor Film Processor Programmer Prong Protector Pulley Pulser Pump Compressor (Air Pump) Pusher Rail Side Rail Reactor Reader Receiver Recorder (Tape, Stripchart, Etc.) Rectifier Reed (Electrically Open) Regulator Relay Repeater Reservoir Resistor Resonator Retainer Reticle Rheostat Ribbon Ring Heart Valve Sewing Ring Slip Ring Rivet Robot Rod Safety Interlock SAW (Surface Acoustic Wave Device) Scale Scaler Scanner Scrambler Screen Screw Screw Tapper Scriber Seal Cup Seal Hermetic Seal Seal Tracheal Servo Shaft Shield Shift Register Shifter Shoulder Support Shunt Shutter Signal Conditioner Simulator Slide Slotter Line Socket Solder Joint Solenoid Spacer Spark Gap Speaker Speech Processor Splicer Spooler Spring Stabilizer Stand Staple Stent Stiffener Stopcock Strain Relief Strip Line Stylet Substrate Sunlamp Suppressor Surgical Graft Suture Switches Control Switches Foot Switch Limit Switch Power Switch Proximity Switch Switch, Push Button Synchronizer Synthesizer Syringe Syringe Drive System Cooling Module Fail-Safe System Gas Delivery System Hydraulic Bed System Hydraulic System Injection System Automatic Injection System Water Purification System Table Table Top Tape Tee Telemetry Equipment Telephone Teleprinter Teletypewriter Temperature Compensator Terminal Terminal Assembly Terminator Test Strip Thermistor Thermocouple Thermostat Thread Thyristor Timer Tip Lead Tip Nozzle Tip Trackball Transceiver Transducer Transformer Transistor Translator Transmission Line Transmitter Transponder Transport Triac Trimmer Trocar Tube CRT (Cathode Ray Tube) Photomultiplier (PM) Tube Pressure Tubing Tube Capillary Tuner Unit Data Acquisition Unit Motor Drive Unit Receiver Stimulator Unit Television Unit Valve Cylinder Valve Hemo Valve Luer Valve One-Way Valve Pilot Balloon Valve Stopcock Valve Valve, Control Valve, Directional Valve, Dump Valve, Exhalation Valve, Flap Valve, Flow Valve, Inhalation Valve, Inlet Port Valve, Inspiratory Valve, Outlet Port Valve, PEEP (Positive End Expiratory Pressure) Valve, Pressure Limit Valve, Relief Valve, Safety Valve, Selector Valve Cam Vaporizer Varistor VDT (Video Display Terminal) Vibrator Viewer Washer Weld Wheel Wheelchair, Wheels Wheelchair, Tires Window Wire Electrical Wire Guidewire Steering Wire Thermocouple Wire Wiring Harness Yoke Manufacturer Evaluation Code Hierarchy Analysis of Data Provided by User/Third Party Analysis of Production Records Communication/Interviews Device Discarded Device Not Accessible for Testing Device Not Manufactured by Reporting Manufacturer Device Not Returned Historical Data Analysis Incomplete Device Returned Insufficient Information Available Testing of Actual/Suspected Device Testing of Device from Other Lot/Batch Retained by Manufacturer Testing of Device from Other Lot/Batch Returned from User Testing of Device from Same Lot/Batch Retained by Manufacturer Testing of Device from Same Lot/Batch Returned from User Testing of Model Variant Testing of Patient Sample or Reference Material Using Competitor's Device Testing of Patient Sample or Reference Material Using Manufacturer's Device Testing of Patient Sample or Reference Material Using Reference Method Testing of Raw/Starting Materials Trend Analysis Type of Investigation Not Yet Determined Manufacturer Evaluation Conclusion Code Hierarchy Appropriate Term/Code Not Available Cause Cannot be Traced to Device Adverse Event Related to Commutability Adverse Event Related to Patient Condition Adverse Event Related to Procedure Cause Not Established Cause Traced to Component Failure Cause Traced to Device Design Design Change Validation Inadequate Design Inadequate for Purpose Human Factors Engineering - Device Difficult to Assemble Human Factors Engineering - Device Difficult to Operate Human Factors Engineering - Device Difficult to Reprocess Missing or Inadequate Safety Measures Cause Traced to Environment Cause Traced to Infrastructure Cause Traced to Labeling Cause Traced to Maintenance Cause Traced to Manufacturing Manufacturing Deficiency Quality Control Deficiency Cause Traced to Training Cause Traced to Transport/Storage Cause Traced to User Cause Traced to Intentional Off-Label, Unapproved, or Contraindicated Use End of Life Problem Identified Failure To Follow Instructions Reuse of Single Use Device Sabotage or Intentional Misuse Shelf Life/Expiration Date Exceeded Unintended Use Error Caused or Contributed to Event Conclusion Not Yet Available Falsified Device Known Inherent Risk of Device No Problem Detected Manufacturer Evaluation Result Code Hierarchy Appropriate Term/Code Not Available Biological Problem Identified Biocompatibility Problem Identified Biological Contamination Endotoxin Contamination Microbial Contamination Cytotoxicity Problem Identified Genotoxicity Problem Identified Carcinogenic Problem Mutagenic Problem Hematological Problem Identified Agglutination Problem Complement Activation Problem Platelet Activation Problem Problem due to Thrombosis Activation Material or Material Leachate Pyrogenic Problem Reproductive Toxicity Problem Identified Unintended Presence of Allergens Clinical Imaging Problem Identified Gradient Induced Field Problem Image Artifact Magnetically-Induced Movement Radiofrequency Induced Overheating Electrical Problem Identified Current Leakage Problem Electrical/Electronic Component Problem Identified Hardware Timing Problem Identified Impedance Problem Identified Insulation Problem Identified Open Circuit Power Source Problem Identified Energy Storage System Problem Loss of Power Power Fluctuation Short Circuit Signal Loss Electromagnetic Compatibility Problem Identified Conducted Interference Electrostatic Discharge Inadequate Immunity Radiofrequency Interference (RFI) Unintended Emission Environment Problem Identified Ambient Light Problem Identified Contamination of Environment by Device Dust or Dirt Problem Identified Environmental Humidity Problem Identified Environmental Pressure Problem Identified Environmental Temperature Problem Identified Interoperability Problem Identified Communications Problem Identified Network Communication Problem Wired Communication Problem Wireless Communication Problem Device Not Compatible With Another Device Incompatible Component/ Accessory Unintended Compatibility Labeling and Instructions for Use/Maintenance Inadequate Labelling and/or Instructions for Use Inadequate or Incorrect Instructions for Maintenance Incorrect Labeling and/or Instructions for Use Maintenance Problem Identified Manufacturing Process Problem Identified Assembly Problem Identified Installation Problem Identified Maintenance of Manufacturing Machinery Packaging Problem Identified Packaging Compromised Packaging Contains Incorrect Device Packaging Contains Unintended Material Packaging Materials Problem Sterilization Problem Identified Material and/or Chemical Problem Identified Degradation Problem Identified Inadequate Physicochemical Properties Inappropriate Material Improper Composition/ Concentration Improper Physical Structure Molecular Structure Problem Incompatible Material Reactivity Problem Identified Tolerance Stack-Up Mechanical Problem Identified Device Migration Friction Problem Identified Incorrect Dimension Leakage/Seal Lubrication Problem Identified Stiffness Problem Identified Stress Problem Identified Deformation Problem Fatigue Problem Fracture Problem Mechanical Shock Problem Vibration Problem Wear Problem No Device Problem Found No Findings Available Operational Problem Identified Device Difficult to Operate Device Incorrectly Reprocessed Device Incorrectly Assembled During Reprocessing Device Incorrectly Cleaned During Reprocessing Device Incorrectly Disinfected/Sterilized During Reprocessing Failure to Calibrate Incorrect Interpretation of Results/Data Optical Problem Identified Light Source Problem Identified Optical Transmission Problem Identified Patient Sample Problem Change in Target Marker/Variant/ Mutant Known Interferent New or Unknown Interferent Pre-analytical Handling Problem Protective System Problem Identified Alarm System Problem Identified Fail-safe Problem Identified Missing or Inadequate Safety Measures Premature Indicator Activation Problem of Device to Self-Test Problem to Auto Stop Reset Problem Shielding Problem Results Pending Completion of Investigation Software Problem Identified Configuration Issue Data Storage or Loss of Data Design Error Data Compression Error Incorrect Algorithm Incorrect Data Definition Interface Design Error Non-Functional Defect Software Timing Problem Erroneous Data Transfer Software Installation Problem Identified Software Maintenance Problem Identified Software Requirement Error Software Runtime Error Software Security Vulnerability Thermal Problem Excessive Cooling Identified Excessive Heating Identified Inadequate Cooling Identified Overheating Problem Identified Transport/Storage Problem Identified Storage Problem Identified Transport Problem Identified Patient Problem Code Hierarchy Abortion Abortion, Complete Abortion, Incomplete Abortion, Induced Abortion, Missed Miscarriage Achalasia Acoustic Trauma Adhesion(s) Adult Respiratory Distress Syndrome AIDS, Acquired Immunodeficiency Syndrome Airway Obstruction Alteration In Body Temperature Ambulation Difficulties Amnionitis Anaphylactoid Anastomose, Failure To Anemia Anesthesia, Insufficient, Light Or Patchy Aneurysm Angina Anxiety Aortic Dissection Apgar Score, Decreased Or Low Decreased Apgar Apheresis Apicectomy Apnea Arachnoiditis, Spinal Arrhythmia Arteriosclerosis Atherosclerosis Ascites Aspiration Asthma Atrial Fibrillation Atrial Flutter Atrial Perforation Atrial Tachycardia Autoimmune Disease Dermatomyositis Lupus Scleroderma Sjogren's Syndrome Autoimmune Reaction Biliary Cirrhosis Blinking, Excessive Blood Gas Measurements, Abnormal Blood Loss Exsanguination Blurred Vision Halo Bradycardia Brain Injury Perinatal Brain Injury Tentorial Tears Breast Lumps Breast Neoplasm Bronchitis Bronchospasm Burning Sensation Cancer Cancer, Breast Lymphoma Anaplastic Large Cell Lymphoma Capsular Bag Tear, Posterior Capsular Contracture Cardiac Arrest Cardiac Perforation Cardiac Tamponade Cardiomyopathy Cardiopulmonary Arrest Cataract Cataract, Induced Cephalohematoma Cerebrospinal Fluid Leakage Cerebrovascular Accident Cervical Changes Chemical Exposure Chest Tightness/Pressure Chills Chorioamnionitis Chronic Obstructive Pulmonary Disease, (COPD) Emphysema, Pulmonary Claudication Closed Capsulotomy Clouding, Central Corneal Coagulopathy Disseminated Intravascular Coagulation (DIC) Cognitive Changes Collapse Coma Complaint, Ill-Defined Complete Heart Block Confusion/Disorientation Congenital Defect/Deformity Neonatal Deformities Neonatal Hearing Impairment Neonatal Hearing Loss Congestive Heart Failure Conjunctivitis Connective Tissue Disease Constipation Convulsion, Clonic Convulsion, Tonic Cornea, Perforation Of Corneal Abrasion Corneal Decompensation Corneal Haze Corneal Infiltrates Corneal Touch Corneal Ulcer Cramp(s) Abdominal Cramps Cross-Patient Exposure To Body Fluids Cusp Tear Cyanosis Cyclitis Cyst(s), Formation Of Cytomegaloviral Retinitis Cytomegalovirus (CMV) Death Sudden Cardiac Death Death, Intrauterine Fetal Debris, Bone Shedding Dehiscence Of Organ Wound Dehiscence Zonular Dehiscence Dehydrated Dementia Deposits Calcification Depression Detached Retina Device Fragments In Patient Diabetic Ketoacidosis Diaphoretic Diarrhea Difficulty Chewing Disability Disc Impingement Discharge Discomfort Disfigurement Dissection Distention Distress Dizziness Dry Eye(s) Dyskinesia Dysphagia Dysphasia Dyspnea Dysuria Edema, Macular EKG/ECG Changes Electric Shock Electro-Mechanical Dissociation Electrocution Electrolyte Imbalance Embolism Air Embolism Pulmonary Embolism Thromboembolism Embolus Emotional Changes Encephalitis Encephalopathy Dementia, Dialysis Endocarditis Endophthalmitis Enzyme Elevation, Cardiac Eructate Esophagus, Laceration(s) Of Esophagus, Perforation Of Exit Block Extravasation Extubate Eye Injury Optical Tissue, Breakdown Of Retina, Damage To Retina, Tear(s) In Facial Nerve Paralysis Fall Fasciitis Fatigue Extreme Exhaustion Feeding Problems Fetal Distress Fever Fibromyositis Fibrosis Scarring Corneal Scar First Use Syndrome Fistula Flashers Flatus Fluid Discharge Purulent Discharge Forced Expiratory Volume, Decreased Forced Expiratory Volume, Increased Foreign Body In Patient Vessel Or Plaque, Device Embedded In Foreign Body Reaction Host-Tissue Reaction Foreign Body Sensation Fracture(s) Fracture, Arm Fracture, Delayed Union Fracture, Hip Fracture, Skull Fracture, Tooth Fungus Gangrene Gastritis Glaucoma Granuloma Hair Loss Head Injury Headache Headache, Lumbar Puncture Healing, Impaired Hearing Impairment Hearing Loss Deafness Heart Failure Left Ventricular Failure Heavier Menses Hematoma Hematuria Hemoconcentration Hemolysis Hemolytic Anemia Hemoptysis Hemorrhage Ecchymosis Hemorrhage, Extradural Hemorrhage, Subarachnoid Hemorrhage, Subdural Hemorrhage, Subgaleal Intermenstrual Bleeding Intracranial Hemorrhage Hemorrhage, Cerebral Hemorrhage, Intraventricular Hemostasis Hemothorax Hepatitis Hernia Hiccups HIV, Human Immunodeficiency Virus Hot Flashes Hydrocephalus Hyperbilirubinemia Hyperemia Hyperglycemia Hypernatremia Hyperplasia Hypersensitivity Hypertension Hyperthermia Hyperventilation Hypervolemia Hyphema Hypoesthesia Hypoesthesia, Arm/Hand Hypoesthesia, Foot/Leg Hypoglycemia Hypopyon Hypotension Hypothermia Hypoventilation Hypovolemia Hypoxia Anoxia Asphyxia Hypoxia In Utero Iatrogenic Source Idioventricular Rhythm Immuno-Deficiency Implant, Failure Of Limited Mobility Of The Implanted Joint Impotence Inadequate Osteointegration Incompetent Cervix Incontinence Infarction, Cerebral Infection Infection, Bacterial Abscess Cellulitis Toxemia Infection, Direct Infection, Fungal Infection, Indirect Infection, Intraocular Infection, Pyrogenic Infection, Subclinical Infection, Upper Respiratory Tract Infection, Urinary Tract Infection, Viral Herpes Venereal Disease Infiltration Of Tissue Inflammation Injury Abrasion Suture Abrasion Bruise Burn(s) Burn, Bowel Burn, Corneal Burn, Thermal Caustic/Chemical Burns First-Degree Burn Lead(s), Burn(s) From Radiation Burn Second-Degree Burn Third-Degree Burn Choking Concussion Contusion Liver Contusion Myocardial Contusion Crushing Injury Laceration(s) Ligament(s), Damage To Nervous System Injury Spinal Cord Injury Perforation Bowel Perforation Organ(s), Perforation Of Sinus, Perforation Of Uterine Perforation Physical Entrapment Rupture Shock, Acoustic Spinal Injury Sprain Strangulation Tissue Damage Tissue Breakdown Erosion Pocket Erosion Skin Erosion Toxicity Ulcer Pressure Sores/Ulcers Vaginal Mucosa Damage Insufficiency, Valvular Aortic Insufficiency Aortic Regurgitation Mitral Insufficiency Mitral Regurgitation Regurgitation, Valvular Tricuspid Insufficiency Tricuspid Regurgitation Intimal Dissection Intraocular Pressure Rise Intraocular Pressure, Delayed, Uncontrolled Iritis Irritability Irritation Skin Irritation Wheal(s) Ischemia Ischemic Heart Disease Itching Jaundice Joint Disorder Arthritis Arthritis, Rheumatoid Joint Dislocation Joint Swelling Keratitis Keratitis, Acanthamoeba Labor, Premature Left Ventricular Dysfunction Left Ventricular Hypertrophy Lethargic Liver Dysfunction Liver Laceration(s) Loss Of Consciousness Fainting Loss Of Pulse Low Cardiac Output Lung, Overinflation Of Malaise Mammogram, Abnormal Mediastinal Shift Memory Loss Meningitis Menstrual Irregularities Microcysts, Epithelial Micturation Urgency Misdiagnosis Missed Dose Missing Value Reason No Known Impact Or Consequence To Patient Mitral Perforation Multiple Organ Failure Muscle Spasm(s) Muscle Stimulation Muscle Weakness Muscular Rigidity Muscular Tics Myocardial Infarction Myocarditis Nausea Necrosis Necrosis Of Flap Tissue Needle Stick/Puncture Neovascularization Nerve Damage Optical Nerve Damage Nerve Proximity Nos (Not Otherwise Specified) Nerve Stimulation, Undesired Neurological Deficit/Dysfunction Neuropathy Nipple Sensation, Changes In/Loss Of Nipple Ulceration No Consequences Or Impact To Patient No Patient Involvement Nonpyrogenic Numbness Obstruction Nasal Obstruction Occlusion Ossification Osteolysis Osteopenia Overdose Radiation Overdose Oversedated Overstimulation Overwear Syndrome Oxygen Saturation, High Oxygen Saturation, Low Pain Arthralgia Chest Pain Heartburn Intraoperative Pain Myalgia Pain, Abdominal Pain, Neck Pain Relief, Inadequate Pallor Palpitations Pannus Formation Paralysis Paresis Paraplegia Peak Expiratory Flowrate, Decreased Peak Expiratory Flowrate, Increased Peeling Pelvic Inflammatory Disease Pericardial Effusion Peripheral Vascular Disease Peritoneal Laceration(s) Peritonitis Peroneal Nerve Palsy Pharyngitis Phlebitis Phosphene Visualization Phototoxicity Pleomorphism Pleural Effusion Pneumonia Bronchopneumonia Pneumothorax Polydipsia Polymyositis Positive Antinuclear Antibodies (ANA) Pregnancy Pregnancy, Ectopic Prolapse Mitral Valve Prolapse Pseudoaneurysm Ptosis Pulmonary Arterial Wedge Pressure, High Pulmonary Arterial Wedge Pressure, Low Pulmonary Arterial Wedge Pressure, Normal Pulmonary Dysfunction Pulmonary Edema Pulmonary Infarction Pulmonary Insufficiency Pulmonary Regurgitation Pulse Pressure, Diminished Pulse, Irregular Pupillary Block Quadriplegia R On T Phenomenon Radiation Exposure, Unintended Radiation Sickness Syndrome Range Of Motion, Loss Of Rash Raynauds Phenomenon Reaction Antibiotics, Reaction To Decreased Sensitivity Increased Sensitivity Reaction, Injection Site Reaction, Local Red Eye(s) Regurgitation Reinfusion Renal Disease, End Stage Renal Failure Reocclusion Respiratory Acidosis Respiratory Alkalosis Respiratory Distress Respiratory Distress Syndrome Of Newborns Respiratory Failure Respiratory Rate, Decreased Respiratory Rate, Increased Retina, Degeneration Of Rheumatic Heart Disease Right Ventricular Dysfunction Right Ventricular Failure Right Ventricular Hypertrophy Scar Excision Scar Tissue Sedation Seizures Seizures, Absence Seizures, Focal Seizures, Focal Motor Seizures, Grand-Mal Sepsis Seroma Shaking/Tremors Shock Lead(s), Shock From Shock, Anaphylactic Shock, Cardiogenic Shock, Hypovolemic Shock, Insulin Shock, Neurogenic Shock, Septic Shock, Surgical Shock, Postoperative Shock, Traumatic Skin Discoloration Erythema Skin Inflammation Radiodermatitis Urticaria Skin Tears Sleep Disturbances Sneezing Sore Throat ST Segment Depression ST Segment Elevation Stacking Breaths Staphylococcus Aureus Stenosis Valvular Stenosis Aortic Stenosis Mitral Stenosis Pulmonary Stenosis Tricuspid Stenosis Stiffness, Neck Suffocation Sunset Syndrome Sweating Swelling Edema Chemosis Corneal Edema Edema, Microcystic Edema, Stromal Swollen Glands Swollen Lymph Nodes Syncope Synovitis Tachycardia Tearing, Excessive Teeth, Sensitivity Of Teratogenic Effects Test Result Patch Test, Abnormal Results Of Therapeutic Effects, Unexpected Therapeutic Response, Decreased Therapeutic Response, Increased Thrombosis Thrombus Thyroid Problems Tingling Tinnitus Toxic Shock Syndrome Toxins In Children Toxoplasmosis, Acquired Toxoplasmosis, Congenital Transient Ischemic Attack Twiddlers Syndrome Twitching UGH (Uveitis-Glaucoma-Hyphema) Syndrome Ulceration Underdose Radiation Underdose Uremia Urinary Frequency Urinary Retention Uveitis Vaginal Discharge Vascular System (Circulation), Impaired Vaso-Vagal Response Vasoconstriction Vasodilatation Venipuncture Ventilator Dependent Ventricle, Abnormality Of Cerebral Ventriculomeglia Ventricular Fibrillation Ventricular Tachycardia Torsades-de-Pointes Ventricular Flutter Vertigo Vessels, Perforation Of Great Vessel Perforation Virus Vision, Impaired Vision, Loss Of Visual Disturbances Vitrectomy Vitreous Floaters Vitreous Fluid, Blood In Vitreous Fluid, Loss Of Vitreous, Detachment Of Vitritis Vomiting Weakness Weight Fluctuations Wound Infection, Post-Operative Wound Infection, Post-Traumatic Wrinkling Problem Code Hierarchy Activation, Positioning or Separation Problem (IMDRF:A15) Activation Problem (IMDRF:A1501) Activation Failure Including Expansion Failures (IMDRF:A150101) Difficult or Delayed Activation (IMDRF:A150102) Premature Activation (IMDRF:A150103) Self-Activation or Keying (IMDRF:A150104) Positioning Problem (IMDRF:A1502) Difficult or Delayed Positioning (IMDRF:A150203) Difficult to Advance (IMDRF:A150205) Difficult to Insert (IMDRF:A150206) Difficult to Remove (IMDRF:A150207) Entrapment of Device (IMDRF:A150208) Failure to Advance (IMDRF:A150204) Malposition of device (IMDRF:A150202) Positioning Failure (IMDRF:A150201) Separation Problem (IMDRF:A1503) Difficult or Delayed Separation (IMDRF:A150302) Premature Separation (IMDRF:A150303) Separation Failure (IMDRF:A150301) Adverse Event Without Identified Device or Use Problem (IMDRF:A24) Appropriate Term/Code Not Available (IMDRF:A27) Calibration Problem (IMDRF:A08) Failure to Calibrate (IMDRF:A0801) Failure to Recalibrate (IMDRF:A0802) Imprecision (IMDRF:A0803) Overcorrection (IMDRF:A0804) Chemical Problem (IMDRF:A03) Device Emits Odor (IMDRF:A0301) Device Ingredient or Reagent Problem (IMDRF:A0302) Clumping in Device or Device Ingredient (IMDRF:A030201) Coagulation in Device or device Ingredient (IMDRF:A030202) Cross Reactivity (IMDRF:A030204) High pH (IMDRF:A030206) Low pH (IMDRF:A030207) Particulates (IMDRF:A030205) Precipitate in Device or device Ingredient (IMDRF:A030203) Improper Chemical Reaction (IMDRF:A0303) Communication or Transmission Problem (IMDRF:A13) Failure to Read Input Signal (IMDRF:A1301) Failure to Transmit Record (IMDRF:A1302) Intermittent Communication Failure (IMDRF:A1303) Telemetry Discrepancy (IMDRF:A1304) Wireless Communication Problem (IMDRF:A1305) Compatibility Problem (IMDRF:A17) Component or Accessory Incompatibility (IMDRF:A1701) Accessory Incompatible (IMDRF:A170101) Component Incompatible (IMDRF:A170102) Device-Device Incompatibility (IMDRF:A1702) Measurement System Incompatibility (IMDRF:A1703) Unintended compatibility (IMDRF:A1704) Computer Software Problem (IMDRF:A11) Application Network Problem (IMDRF:A1101) Application Program Problem (IMDRF:A1102) Application Program Freezes, Becomes Nonfunctional (IMDRF:A110201) Application Program Problem: Dose Calculation Error (IMDRF:A110202) Application Program Problem: Medication Error (IMDRF:A110203) Application Program Problem: Parameter Calculation Error (IMDRF:A110204) Application Program Problem: Power Calculation Error (IMDRF:A110205) Application Program Version or Upgrade Problem (IMDRF:A110206) Problem with Software Installation (IMDRF:A110207) Unintended Application Program Shut Down (IMDRF:A110208) Computer Operating System Problem (IMDRF:A1104) Operating System Becomes Nonfunctional (IMDRF:A110401) Operating System Version or Upgrade Problem (IMDRF:A110402) Computer System Security Problem (IMDRF:A1105) Application Security Problem (IMDRF:A110501) Unauthorized Access to Computer System (IMDRF:A110502) Data Back-Up Problem (IMDRF:A1106) Failure to Back-Up (IMDRF:A110601) Failure to Convert to Back-Up (IMDRF:A110602) Data Problem (IMDRF:A1107) Loss of Data (IMDRF:A110701) Patient Data Problem (IMDRF:A110702) Date/Time-Related Software Problem (IMDRF:A1108) Program or Algorithm Execution Problem (IMDRF:A1103) Delayed Program or Algorithm Execution (IMDRF:A110301) Intermittent Program or Algorithm Execution (IMDRF:A110302) Program or Algorithm Execution Failure (IMDRF:A110303) Connection Problem (IMDRF:A12) Blocked Connection (IMDRF:A1201) Decoupling (IMDRF:A1202) Disconnection (IMDRF:A1203) Failure to Disconnect (IMDRF:A1204) Fitting Problem (IMDRF:A1208) Incomplete or Inadequate Connection (IMDRF:A1207) Loose or Intermittent Connection (IMDRF:A1205) Misconnection (IMDRF:A1206) Contamination / decontamination Problem (IMDRF:A18) Contamination During Use (IMDRF:A1801) Biofilm coating in Device (IMDRF:A180101) Contamination of Device Ingredient or Reagent (IMDRF:A180102) Device Contamination with Body Fluid (IMDRF:A180103) Device Contamination with Chemical or Other Material (IMDRF:A180104) Microbial Contamination of Device (IMDRF:A180105) Device Contaminated during manufacture or shipping (IMDRF:A1802) Device Reprocessing Problem (IMDRF:A1803) Failure to Clean Adequately (IMDRF:A180301) Failure to Disinfect (IMDRF:A180302) Flushing problem (IMDRF:A180303) Problem with Removal of Enzymatic Cleaner (IMDRF:A180304) Problem with Sterilization (IMDRF:A180305) Residue After Decontamination (IMDRF:A180306) Electrical /Electronic Property Problem (IMDRF:A07) Arcing (IMDRF:A0703) Arcing at Paddles (IMDRF:A070301) Arcing of Electrodes (IMDRF:A070302) Battery Problem (IMDRF:A0705) Battery Problem: High Impedance (IMDRF:A070501) Battery Problem: Low Impedance (IMDRF:A070502) Failure to Run on Battery (IMDRF:A070503) Premature Discharge of Battery (IMDRF:A070504) Capturing Problem (IMDRF:A0701) Failure to Capture (IMDRF:A070101) High Capture Threshold (IMDRF:A070102) Intermittent Capture (IMDRF:A070103) Unstable Capture Threshold (IMDRF:A070104) Charging Problem (IMDRF:A0706) Aborted Charge (IMDRF:A070601) Delayed Charge Time (IMDRF:A070602) Failure to Charge (IMDRF:A070603) Circuit Failure (IMDRF:A0721) Capacitative Coupling (IMDRF:A072101) Electrical Shorting (IMDRF:A072102) Intermittent Continuity (IMDRF:A072103) Continuous Firing (IMDRF:A0702) Defibrillation Problem (IMDRF:A0713) Failure to Deliver Shock (IMDRF:A071301) Inappropriate Shock (IMDRF:A071302) Intermittent Shock (IMDRF:A071303) Device Sensing Problem (IMDRF:A0709) Decreased Sensitivity (IMDRF:A070901) Failure to Analyze Signal (IMDRF:A070903) Failure to Select Signal (IMDRF:A070904) Failure to Sense (IMDRF:A070908) High Sensing Threshold (IMDRF:A070905) Incorrect Interpretation of signal (IMDRF:A070912) Increased Sensitivity (IMDRF:A070902) Loss of Threshold (IMDRF:A070907) Low Sensing Threshold (IMDRF:A070906) Over-Sensing (IMDRF:A070909) Sensing Intermittently (IMDRF:A070911) Under-Sensing (IMDRF:A070910) Electrical Overstress (IMDRF:A0716) Electro-Static Discharge (IMDRF:A0717) Electromagnetic Compatibility Problem (IMDRF:A0720) Electromagnetic Interference (IMDRF:A072001) Radiofrequency Interference (RFI) (IMDRF:A072002) Failure to Conduct (IMDRF:A0710) Failure to Discharge (IMDRF:A0707) Failure to Shut Off (IMDRF:A0718) Device Remains Activated (IMDRF:A071801) Grounding Malfunction (IMDRF:A0715) Impedance Problem (IMDRF:A0722) High impedance (IMDRF:A072201) Low impedance (IMDRF:A072202) Interrogation Problem (IMDRF:A0711) Difficult to Interrogate (IMDRF:A071101) Failure to Interrogate (IMDRF:A071102) Pacing Problem (IMDRF:A0712) Failure to Convert Rhythm (IMDRF:A071201) Inaccurate Synchronization (IMDRF:A071202) Inappropriate waveform (IMDRF:A071203) No Pacing (IMDRF:A071204) Pacemaker Found in Back-Up Mode (IMDRF:A071205) Pacing Asynchronously (IMDRF:A071206) Pacing Inadequately (IMDRF:A071207) Pacing Intermittently (IMDRF:A071208) Pocket Stimulation (IMDRF:A071209) Power Problem (IMDRF:A0708) Complete Loss of power (IMDRF:A070801) Failure to Power Up (IMDRF:A070803) Intermittent loss of power (IMDRF:A070802) Unintended power up (IMDRF:A070804) Sparking (IMDRF:A0704) Unexpected Shutdown (IMDRF:A0719) Unintended Electrical Shock (IMDRF:A0714) Environmental Compatibility Problem (IMDRF:A19) Ambient Noise Problem (IMDRF:A1901) Ambient Temperature Problem (IMDRF:A1902) Device Unsafe to Use in Environment (IMDRF:A1907) Electrical Power Problem (IMDRF:A1910) Emergency Power Failure (IMDRF:A191001) Loss of Power (IMDRF:A191002) Power Conditioning Problem (IMDRF:A191003) Environmental Particulates (IMDRF:A1908) Fumes or Vapors (IMDRF:A1903) Fungus in Device Environment (IMDRF:A1904) Medical Gas Supply Problem (IMDRF:A1909) Moisture or Humidity Problem (IMDRF:A1905) Moisture Damage (IMDRF:A190501) Ventilation Problem in Device Environment (IMDRF:A1906) Fogging (IMDRF:A190601) Human-Device Interface Problem (IMDRF:A22) Device Difficult to Maintain (IMDRF:A2203) Device Difficult to Program or Calibrate (IMDRF:A2202) Device Difficult to Setup or Prepare (IMDRF:A2201) Inadequate User Interface (IMDRF:A2204) Infusion or Flow Problem (IMDRF:A14) Deflation Problem (IMDRF:A1401) Difficult to Flush (IMDRF:A1410) Excess Flow or Over-Infusion (IMDRF:A1402) Filling Problem (IMDRF:A1403) Inability to Auto-Fill (IMDRF:A140301) Overfill (IMDRF:A140302) Short Fill (IMDRF:A140303) Volume Accuracy Problem (IMDRF:A140304) Filtration Problem (IMDRF:A1404) Inadequate Filtration Process (IMDRF:A140401) Inadequate Ultra Filtration (IMDRF:A140402) Improper Flow or Infusion (IMDRF:A1405) Backflow (IMDRF:A140501) Free or Unrestricted Flow (IMDRF:A140502) Gradient Increase (IMDRF:A140503) Inaccurate Delivery (IMDRF:A140504) Inaccurate Flow rate (IMDRF:A140505) Intermittent Infusion (IMDRF:A140506) Reflux within Device (IMDRF:A140507) Restricted Flow rate (IMDRF:A140508) Tidal Volume Fluctuations (IMDRF:A140509) Inflation Problem (IMDRF:A1406) Insufficient Flow or Under Infusion (IMDRF:A1407) No Flow (IMDRF:A1408) Failure to Deliver (IMDRF:A140801) Failure to Infuse (IMDRF:A140802) Inability to Irrigate (IMDRF:A140803) Obstruction of Flow (IMDRF:A1409) Complete Blockage (IMDRF:A140901) Partial Blockage (IMDRF:A140902) Pressure Problem (IMDRF:A1411) Decrease in Pressure (IMDRF:A141101) Increase in Pressure (IMDRF:A141102) No Pressure (IMDRF:A141103) Priming Problem (IMDRF:A1414) Failure to Prime (IMDRF:A141401) Incomplete or Inadequate Priming (IMDRF:A141402) Pumping Problem (IMDRF:A1412) Decreased Pump Speed (IMDRF:A141201) Failure to Pump (IMDRF:A141203) Increased Pump Speed (IMDRF:A141202) Pumping Stopped (IMDRF:A141204) Suction Problem (IMDRF:A1413) Decrease in Suction (IMDRF:A141301) Increase in Suction (IMDRF:A141302) Suction Failure (IMDRF:A141303) Installation-Related Problem (IMDRF:A20) Misassembled During Installation (IMDRF:A2001) Insufficient Information (IMDRF:A26) Labelling, Instructions for Use or Training Problem (IMDRF:A21) Device Markings / Labelling Problem (IMDRF:A2101) Expiration Date Error (IMDRF:A210101) Illegible Information (IMDRF:A210102) Inaccurate Information (IMDRF:A210103) Missing Information (IMDRF:A210105) Unclear Information (IMDRF:A210104) Inadequate Instructions for Healthcare Professional (IMDRF:A2103) Inadequate Instructions for Non-Healthcare Professional (IMDRF:A2104) Inadequate or Insufficient Training (IMDRF:A2105) Lack of Maintenance Documentation or Guidelines (IMDRF:A2102) Manufacturing, Packaging or Shipping Problem (IMDRF:A02) Defective Component (IMDRF:A0202) Defective Device (IMDRF:A0203) Device Damaged Prior to Use (IMDRF:A0204) Device Misassembled During Manufacturing / Shipping (IMDRF:A0206) Component Misassembled (IMDRF:A020601) Component Missing (IMDRF:A020602) Packaging Problem (IMDRF:A0205) Difficult to Open or Remove Packaging Material (IMDRF:A020501) Incomplete or Missing Packaging (IMDRF:A020502) Tear, Rip or Hole in Device Packaging (IMDRF:A020504) Unsealed Device Packaging (IMDRF:A020503) Product Quality Problem (IMDRF:A0201) Dull, Blunt (IMDRF:A020101) Nonstandard device (IMDRF:A020102) Shipping Damage or Problem (IMDRF:A0207) Delivered as Unsterile Product (IMDRF:A020701) Material Integrity Problem (IMDRF:A04) Break (IMDRF:A0401) Fracture (IMDRF:A040101) Loss of or Failure to Bond (IMDRF:A040102) Material Fragmentation (IMDRF:A040103) Solder Joint Fracture (IMDRF:A040104) Burst Container or Vessel (IMDRF:A0402) Crack (IMDRF:A0404) Degraded (IMDRF:A0405) Calcified (IMDRF:A040501) Corroded (IMDRF:A040502) Flaked (IMDRF:A040505) Material Erosion (IMDRF:A040503) Naturally Worn (IMDRF:A040507) Peeled / Delaminated (IMDRF:A040506) Pitted (IMDRF:A040504) Unraveled Material (IMDRF:A040508) Explosion (IMDRF:A0403) Material Deformation (IMDRF:A0406) Deformation Due to Compressive Stress (IMDRF:A040601) Dent in Material (IMDRF:A040602) Failure to Fold (IMDRF:A040603) Failure to Unfold or Unwrap (IMDRF:A040604) Material Frayed (IMDRF:A040605) Material Invagination (IMDRF:A040606) Material Too Rigid or Stiff (IMDRF:A040607) Material Too Soft / Flexible (IMDRF:A040608) Material Twisted / Bent (IMDRF:A040609) Melted (IMDRF:A040610) Stretched (IMDRF:A040611) Material Discolored (IMDRF:A0407) Material Disintegration (IMDRF:A0408) Material Opacification (IMDRF:A0409) Material Perforation (IMDRF:A0410) Material Puncture / Hole (IMDRF:A041001) Material Protrusion / Extrusion (IMDRF:A0411) Material Rupture (IMDRF:A0412) Material Separation (IMDRF:A0413) Material Split, Cut or Torn (IMDRF:A0414) Scratched Material (IMDRF:A0415) Mechanical Problem (IMDRF:A05) Detachment of Device or device Component (IMDRF:A0501) Device Damaged by Another Device (IMDRF:A0502) Ejection Problem (IMDRF:A0503) Failure to Eject (IMDRF:A050301) Unintended Ejection (IMDRF:A050302) Firing Problem (IMDRF:A0505) Failure to Fire (IMDRF:A050501) Misfire (IMDRF:A050502) Leak / Splash (IMDRF:A0504) Fluid Leak (IMDRF:A050401) Gas Leak (IMDRF:A050402) Gel Leak (IMDRF:A050403) Perivalvular Leak (IMDRF:A050405) Radiation Leak (IMDRF:A050404) Mechanical Jam (IMDRF:A0506) Mechanics Altered (IMDRF:A0507) Failure to Align (IMDRF:A050701) Failure to Cut (IMDRF:A050702) Failure to Cycle (IMDRF:A050703) Failure to Form Staple (IMDRF:A050704) Noise, Audible (IMDRF:A0508) Physical Resistance / Sticking (IMDRF:A0509) Retraction Problem (IMDRF:A0510) Structural Problem (IMDRF:A0511) Collapse (IMDRF:A051101) Difficult to Fold or Unfold (IMDRF:A051103) Difficult to Open or Close (IMDRF:A051104) Incomplete Coaptation (IMDRF:A051105) Sharp Edges (IMDRF:A051102) Unintended Movement (IMDRF:A05012) Device Dislodged or Dislocated (IMDRF:A051201) Device Fell (IMDRF:A051203) Device Slipped (IMDRF:A051204) Device Tipped Over (IMDRF:A051202) Unintended Collision (IMDRF:A051205) Unintended System Motion (IMDRF:A051206) Unstable (IMDRF:A051207) Vibration (IMDRF:A051208) No Apparent Adverse Event (IMDRF:A25) Optical Problem (IMDRF:A06) Misfocusing (IMDRF:A0601) Optical Decentration (IMDRF:A0602) Optical Discoloration (IMDRF:A0603) Optical Distortion (IMDRF:A0604) Optical Obstruction (IMDRF:A0605) Output Problem (IMDRF:A09) Audible Prompt / Feedback (IMDRF:A0901) Inappropriate Audible Prompt / Feedback (IMDRF:A090101) Inaudible or Unclear Audible Prompt / Feedback (IMDRF:A090102) No Audible Prompt / Feedback (IMDRF:A090103) Display or Visual Feedback Problem (IMDRF:A0902) Device Displays Incorrect Message (IMDRF:A090201) Display Difficult to Read (IMDRF:A090202) Erratic or Intermittent Display (IMDRF:A090203) Image Display Error / Artifact (IMDRF:A090204) Image Orientation Incorrect (IMDRF:A090205) No Display / Image (IMDRF:A090206) No Visual Prompts / Feedback (IMDRF:A090207) Poor Quality Image (IMDRF:A090208) Visual Prompts will not Clear (IMDRF:A090209) Energy Output Problem (IMDRF:A0904) Energy Spectrum Incorrect (IMDRF:A090401) Failure to Deliver Energy (IMDRF:A090402) Intermittent Energy Output (IMDRF:A090403) Output above Specifications (IMDRF:A090404) Output below Specifications (IMDRF:A090405) Therapeutic or Diagnostic Output Failure (IMDRF:A090406) Therapy Delivered to Incorrect Body Area (IMDRF:A090407) Gas output problem (IMDRF:A0906) Incorrect, Inadequate or Imprecise Result or Readings (IMDRF:A0908) Failure to Obtain Sample (IMDRF:A090802) False Negative Result (IMDRF:A090803) False Positive Result (IMDRF:A090804) High Readings (IMDRF:A090807) High Test Results (IMDRF:A090809) Incorrect Measurement (IMDRF:A090805) Low Readings (IMDRF:A090808) Low Test Results (IMDRF:A090810) Missing Test Results (IMDRF:A090812) Non Reproducible Results (IMDRF:A090806) Signal Artifact (IMDRF:A090801) Unable to Obtain Readings (IMDRF:A090811) No Device Output (IMDRF:A0907) Radiation Output Problem (IMDRF:A0905) Radiation Output Failure (IMDRF:A090501) Radiation Overexposure (IMDRF:A090502) Radiation Underexposure (IMDRF:A090503) Unexpected/Unintended Radiation Output (IMDRF:A090504) Tactile Prompts / Feedback (IMDRF:A0903) Inappropriate Tactile Prompt / Feedback (IMDRF:A090301) No Tactile Prompts / Feedback (IMDRF:A090302) Unexpected Therapeutic Results (IMDRF:A0909) Patient Device Interaction Problem (IMDRF:A01) Loosening of Implant Not Related to Bone-Ingrowth (IMDRF:A0103) Migration or Expulsion of Device (IMDRF:A0104) Expulsion (IMDRF:A010401) Migration (IMDRF:A010402) Osseointegration Problem (IMDRF:A0102) Failure to Osseointegrate (IMDRF:A010201) Loss of Osseointegration (IMDRF:A010202) Patient-Device Incompatibility (IMDRF:A0101) Biocompatibility (IMDRF:A010101) Device Appears to Trigger Rejection (IMDRF:A010102) Inadequacy of Device Shape and/or Size (IMDRF:A010103) Protective Measures Problem (IMDRF:A16) Device Alarm System (IMDRF:A1601) Alarm Not Visible (IMDRF:A160101) Defective Alarm (IMDRF:A160106) Delayed Alarm (IMDRF:A160104) False Alarm (IMDRF:A160105) Low Audible Alarm (IMDRF:A160103) No Audible Alarm (IMDRF:A160102) Fail-Safe Problem (IMDRF:A1602) Fail-Safe Did Not Operate (IMDRF:A160201) No Fail-Safe Mechanism (IMDRF:A160202) Failure of Device to Self-Test (IMDRF:A1603) Failure to Auto Stop (IMDRF:A1604) Premature Indicator Activation (IMDRF:A1606) Premature Elective Replacement Indicator (IMDRF:A160601) Premature End-of-Life Indicator (IMDRF:A160602) Reset Problem (IMDRF:A1605) Failure to Reset (IMDRF:A160501) Failure to Zero (IMDRF:A160502) Inappropriate or Unexpected Reset (IMDRF:A160503) Shielding Failure (IMDRF:A1607) Temperature Problem (IMDRF:A10) Excessive Cooling (IMDRF:A1001) Excessive Heating (IMDRF:A1002) Fire (IMDRF:A1007) Flare or Flash (IMDRF:A1008) Insufficient Cooling (IMDRF:A1003) Insufficient Heating (IMDRF:A1004) Overheating of Device (IMDRF:A1005) Smoking (IMDRF:A1009) Thermal Decomposition of Device (IMDRF:A1006) Use of Device Problem (IMDRF:A23) Device Handling Problem (IMDRF:A2301) Improper or Incorrect Procedure or Method (IMDRF:A2303) Misassembled (IMDRF:A2305) Misassembly by Users (IMDRF:A230501) Misassembly during Maintenance / Repair (IMDRF:A230502) Off-Label Use (IMDRF:A2304) Use of Incorrect Control Settings (IMDRF:A2302)