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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 9
AIREHEALTH INC.
  SUBSTANTIALLY EQUIVALENT 1
BREATHESUITE INC
  SUBSTANTIALLY EQUIVALENT 1
COGNITA LABS, LLC
  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
MEDLINE INDUSTIRES, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDLINE INDUSTRIES LP
  SUBSTANTIALLY EQUIVALENT 1
MEDLINE INDUSTRIES, INC
  SUBSTANTIALLY EQUIVALENT 1
MICROBASE TECHNOLOGY CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
MONAGHAN MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
OCHSNER CLINIC FOUNDATION
  SUBSTANTIALLY EQUIVALENT 1
PARI RESPIRATORY EQUIPMENT, INC.
  SUBSTANTIALLY EQUIVALENT 2
QINGDAO FUTURE MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
RECIPROCAL LABS CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
SHENZHEN HOMED MEDICAL DEVICE CO,.LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN HOMED MEDICAL DEVICE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN IVANKACA TECHNOLOGY CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
  1.  K201397  Ultrasonic Mesh Nebulizer
THE RITEDOSE CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
TRUDELL MEDICAL INTERNATIONAL
  SUBSTANTIALLY EQUIVALENT 4
VAPOTHERM INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2018 162 162
2019 185 185
2020 117 117
2021 161 161
2022 55 55
2023 83 83

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Deliver 185 185
Connection Problem 70 70
Leak/Splash 62 62
Disconnection 46 46
Break 40 40
Fluid/Blood Leak 23 23
Fitting Problem 22 22
Defective Device 19 19
Mechanical Problem 17 17
Electrical /Electronic Property Problem 17 17
Use of Device Problem 16 16
Improper Flow or Infusion 15 15
Output Problem 15 15
Gas/Air Leak 14 14
Material Rupture 14 14
No Flow 13 13
Therapeutic or Diagnostic Output Failure 13 13
Insufficient Information 12 12
Patient Device Interaction Problem 11 11
Detachment of Device or Device Component 11 11
Fire 11 11
Defective Component 10 10
Infusion or Flow Problem 10 10
Adverse Event Without Identified Device or Use Problem 8 8
Appropriate Term/Code Not Available 7 7
Degraded 7 7
Loose or Intermittent Connection 6 6
Inaccurate Delivery 6 6
Obstruction of Flow 6 6
Improper or Incorrect Procedure or Method 5 5
Smoking 5 5
Incorrect, Inadequate or Imprecise Result or Readings 5 5
Sparking 5 5
Melted 5 5
Overheating of Device 5 5
Failure to Power Up 4 4
Contamination 4 4
Component Missing 4 4
Product Quality Problem 4 4
Device Operates Differently Than Expected 4 4
Manufacturing, Packaging or Shipping Problem 3 3
Material Integrity Problem 3 3
Noise, Audible 3 3
Unexpected Shutdown 3 3
Device Displays Incorrect Message 3 3
Charging Problem 3 3
Display or Visual Feedback Problem 3 3
Off-Label Use 3 3
Device Emits Odor 2 2
Thermal Decomposition of Device 2 2
Burst Container or Vessel 2 2
Detachment Of Device Component 2 2
Incomplete or Missing Packaging 2 2
Malposition of Device 2 2
Insufficient Flow or Under Infusion 2 2
Separation Problem 2 2
Complete Loss of Power 2 2
Material Split, Cut or Torn 2 2
Device Contamination with Chemical or Other Material 2 2
Electrical Shorting 2 2
No Pressure 2 2
Packaging Problem 2 2
Pressure Problem 2 2
Protective Measures Problem 2 2
Temperature Problem 2 2
Power Problem 1 1
Human-Device Interface Problem 1 1
Failure to Shut Off 1 1
Device-Device Incompatibility 1 1
Material Twisted/Bent 1 1
Mechanics Altered 1 1
Moisture or Humidity Problem 1 1
Explosion 1 1
Device Handling Problem 1 1
Activation Failure 1 1
Failure to Eject 1 1
Physical Resistance/Sticking 1 1
Device Fell 1 1
Inappropriate Audible Prompt/Feedback 1 1
Device Damaged Prior to Use 1 1
Difficult or Delayed Activation 1 1
Difficult to Remove 1 1
Material Too Rigid or Stiff 1 1
Unexpected Therapeutic Results 1 1
Unstable 1 1
Material Separation 1 1
Patient-Device Incompatibility 1 1
Battery Problem 1 1
Chemical Problem 1 1
Contamination /Decontamination Problem 1 1
Communication or Transmission Problem 1 1
Device Markings/Labelling Problem 1 1
Contamination of Device Ingredient or Reagent 1 1
Component Falling 1 1
Component Incompatible 1 1
Device Alarm System 1 1
No Audible Alarm 1 1
Failure to Charge 1 1
Corroded 1 1
Material Disintegration 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 231 231
No Clinical Signs, Symptoms or Conditions 205 205
No Known Impact Or Consequence To Patient 93 93
No Patient Involvement 80 80
Insufficient Information 54 54
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 8 8
No Information 8 8
Low Oxygen Saturation 8 8
Unspecified Respiratory Problem 7 7
Dyspnea 7 7
Respiratory Distress 6 6
Aspiration/Inhalation 5 5
Unintended Extubation 5 5
Asthma 4 4
Apnea 3 3
Dizziness 3 3
Bronchospasm 3 3
No Code Available 3 3
Fibrosis 2 2
Urinary Frequency 2 2
Sore Throat 2 2
High Pulmonary Arterial Wedge Pressure 2 2
Swelling/ Edema 2 2
Cough 2 2
Death 2 2
Unspecified Infection 2 2
Itching Sensation 2 2
Pneumonia 2 2
Arrhythmia 2 2
Airway Obstruction 2 2
Headache 2 2
Bacterial Infection 2 2
Bradycardia 2 2
Burn(s) 2 2
Cardiopulmonary Arrest 2 2
Chest Pain 1 1
Cyanosis 1 1
Hemorrhage/Bleeding 1 1
Hypersensitivity/Allergic reaction 1 1
Low Blood Pressure/ Hypotension 1 1
Abrasion 1 1
Pneumothorax 1 1
Pulmonary Edema 1 1
Rash 1 1
Laceration(s) 1 1
Occlusion 1 1
Peeling 1 1
Ulcer 1 1
Right Ventricular Dysfunction 1 1
Burning Sensation 1 1
Fatigue 1 1
Pulmonary Hypertension 1 1
Respiratory Arrest 1 1
Respiratory Insufficiency 1 1
Skin Inflammation/ Irritation 1 1
Increased Respiratory Rate 1 1
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
Superficial (First Degree) Burn 1 1
Patient Problem/Medical Problem 1 1
Heart Failure/Congestive Heart Failure 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
5 Valeant Pharmacueticals International II Jan-17-2018
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