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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device nebulizer (direct patient interface)
Product CodeCAF
Regulation Number 868.5630
Device Class 2


Premarket Reviews
ManufacturerDecision
ADHERIUM (NZ) LTD
  SUBSTANTIALLY EQUIVALENT 6
AEROGEN LTD.
  SUBSTANTIALLY EQUIVALENT 1
AIREHEALTH INC.
  SUBSTANTIALLY EQUIVALENT 1
BREATHESUITE INC
  SUBSTANTIALLY EQUIVALENT 1
COGNITA LABS, LLC
  SUBSTANTIALLY EQUIVALENT 1
DONGGUAN SIMZO ELECTRONIC TECHNOLOGY CO.LTD.
  SUBSTANTIALLY EQUIVALENT 1
EXCELLENTCARE MEDICAL (HUIZHOU) LTD.
  SUBSTANTIALLY EQUIVALENT 1
FEELLIFE HEALTH INC.
  SUBSTANTIALLY EQUIVALENT 1
FISHER & PAYKEL HEALTHCARE LIMITED
  SUBSTANTIALLY EQUIVALENT 1
GLOBALCARE MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
HCMED INNOVATIONS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
MANKIND PHARMA LIMITED
  SUBSTANTIALLY EQUIVALENT 1
MEDLINE INDUSTIRES, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDLINE INDUSTRIES LP
  SUBSTANTIALLY EQUIVALENT 1
  1.  K230602  Hudson RCI® TurboMist™ Nebulizer System
MEDLINE INDUSTRIES, INC
  SUBSTANTIALLY EQUIVALENT 1
MEDLINE INDUSTRIES, LP
  SUBSTANTIALLY EQUIVALENT 1
MONAGHAN MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
OCHSNER CLINIC FOUNDATION
  SUBSTANTIALLY EQUIVALENT 1
PARI RESPIRATORY EQUIPMENT, INC.
  SUBSTANTIALLY EQUIVALENT 2
RECIPROCAL LABS CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN HOMED MEDICAL DEVICE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN IVANKACA TECHNOLOGY CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
THE RITEDOSE CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
TRUDELL MEDICAL INTERNATIONAL
  SUBSTANTIALLY EQUIVALENT 2
VAPOTHERM INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 185 185
2020 117 117
2021 161 161
2022 55 55
2023 104 104
2024 28 28

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Deliver 155 155
Connection Problem 55 55
Leak/Splash 44 44
Break 35 35
Disconnection 23 23
Fluid/Blood Leak 18 18
Defective Device 18 18
Use of Device Problem 17 17
Mechanical Problem 16 16
Improper Flow or Infusion 15 15
Output Problem 13 13
Therapeutic or Diagnostic Output Failure 13 13
Fire 12 12
Insufficient Information 11 11
Infusion or Flow Problem 10 10
Patient Device Interaction Problem 10 10
Material Rupture 10 10
Defective Component 10 10
Gas/Air Leak 9 9
Adverse Event Without Identified Device or Use Problem 8 8
Fitting Problem 8 8
Smoking 7 7
Detachment of Device or Device Component 7 7
Electrical /Electronic Property Problem 7 7
Appropriate Term/Code Not Available 7 7
No Flow 7 7
Unexpected Shutdown 6 6
Degraded 5 5
Contamination 5 5
Loose or Intermittent Connection 5 5
Melted 5 5
Overheating of Device 5 5
Failure to Power Up 5 5
Sparking 5 5
Incorrect, Inadequate or Imprecise Result or Readings 5 5
Component Missing 5 5
Inaccurate Delivery 4 4
Improper or Incorrect Procedure or Method 4 4
Product Quality Problem 4 4
Material Integrity Problem 4 4
Off-Label Use 3 3
Device Emits Odor 3 3
Corroded 3 3
Thermal Decomposition of Device 3 3
Insufficient Flow or Under Infusion 3 3
Obstruction of Flow 3 3
Device Displays Incorrect Message 3 3
Malposition of Device 2 2
Charging Problem 2 2
Electrical Shorting 2 2
Decrease in Pressure 2 2
Device Contamination with Chemical or Other Material 2 2
Incomplete or Missing Packaging 2 2
Burst Container or Vessel 2 2
Manufacturing, Packaging or Shipping Problem 2 2
Packaging Problem 2 2
Material Split, Cut or Torn 2 2
Pressure Problem 2 2
Protective Measures Problem 2 2
Temperature Problem 2 2
Complete Loss of Power 2 2
Separation Problem 2 2
Explosion 1 1
Failure to Eject 1 1
Physical Resistance/Sticking 1 1
Excessive Heating 1 1
Incomplete or Inadequate Connection 1 1
Power Problem 1 1
No Pressure 1 1
Device Handling Problem 1 1
Activation Failure 1 1
Noise, Audible 1 1
Material Twisted/Bent 1 1
Mechanics Altered 1 1
Moisture or Humidity Problem 1 1
Failure to Charge 1 1
Component Incompatible 1 1
No Audible Alarm 1 1
Loss of or Failure to Bond 1 1
Material Disintegration 1 1
Display or Visual Feedback Problem 1 1
Fracture 1 1
Material Fragmentation 1 1
Material Frayed 1 1
Labelling, Instructions for Use or Training Problem 1 1
No Device Output 1 1
Nonstandard Device 1 1
Incorrect Measurement 1 1
Restricted Flow rate 1 1
Material Puncture/Hole 1 1
Difficult to Remove 1 1
Device Difficult to Setup or Prepare 1 1
Failure to Run on Battery 1 1
Inappropriate Audible Prompt/Feedback 1 1
Difficult or Delayed Activation 1 1
Unexpected Therapeutic Results 1 1
Material Too Rigid or Stiff 1 1
Material Separation 1 1
Failure to Shut Off 1 1
Device Ingredient or Reagent Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 239 239
No Consequences Or Impact To Patient 149 149
Insufficient Information 60 60
No Known Impact Or Consequence To Patient 59 59
No Patient Involvement 52 52
Low Oxygen Saturation 11 11
Dyspnea 10 10
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 8 8
Unspecified Respiratory Problem 7 7
Unintended Extubation 5 5
Aspiration/Inhalation 5 5
No Information 4 4
Swelling/ Edema 3 3
Asthma 3 3
Dizziness 3 3
Pneumothorax 2 2
Urinary Frequency 2 2
Sore Throat 2 2
Unspecified Infection 2 2
Itching Sensation 2 2
Respiratory Distress 2 2
Bacterial Infection 2 2
Bradycardia 2 2
Burn(s) 2 2
Airway Obstruction 2 2
Apnea 2 2
Arrhythmia 2 2
Headache 2 2
Hypersensitivity/Allergic reaction 2 2
Cough 2 2
Pulmonary Hypertension 2 2
Respiratory Insufficiency 2 2
Fibrosis 2 2
High Pulmonary Arterial Wedge Pressure 2 2
Bronchospasm 2 2
Increased Respiratory Rate 2 2
Sleep Dysfunction 1 1
Eye Burn 1 1
Burn, Thermal 1 1
Underdose 1 1
Electric Shock 1 1
Missed Dose 1 1
Chemical Exposure 1 1
Decreased Respiratory Rate 1 1
No Code Available 1 1
Heart Failure/Congestive Heart Failure 1 1
Wheezing 1 1
Respiratory Arrest 1 1
Skin Inflammation/ Irritation 1 1
Low Blood Pressure/ Hypotension 1 1
Hypoxia 1 1
Hemorrhage/Bleeding 1 1
Fatigue 1 1
Chest Pain 1 1
Cyanosis 1 1
Death 1 1
Right Ventricular Dysfunction 1 1
Tachycardia 1 1
Burning Sensation 1 1
Hot Flashes/Flushes 1 1
Occlusion 1 1
Peeling 1 1
Pneumonia 1 1
Ulcer 1 1
Pulmonary Edema 1 1
Rash 1 1
Abrasion 1 1

Recalls
Manufacturer Recall Class Date Posted
1 MEDLINE INDUSTRIES, LP - Northfield I Sep-14-2023
2 Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company I Feb-04-2019
3 SANRAI INTERNATIONAL LLC II Mar-26-2019
4 Smiths Medical ASD Inc. II Apr-29-2021
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