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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)
Regulation Description Nebulizer.
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
ENCHANT TEK 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
  1.  K211560  Airvo Nebulizer Adapter
GLOBALCARE MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
HCMED INNOVATIONS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
JOYTECH HEALTHCARE CO. , LTD.
  SUBSTANTIALLY EQUIVALENT 1
MANKIND PHARMA LIMITED
  SUBSTANTIALLY EQUIVALENT 1
MEDLINE INDUSTIRES, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDLINE INDUSTRIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDLINE INDUSTRIES, LP
  SUBSTANTIALLY EQUIVALENT 2
MONAGHAN MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
OCHSNER CLINIC FOUNDATION
  SUBSTANTIALLY EQUIVALENT 1
PARI RESPIRATORY EQUIPMENT, INC.
  SUBSTANTIALLY EQUIVALENT 3
QINGDAO FUTURE MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
RECIPROCAL LABS CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN HOMED MEDICAL DEVICE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN IVANKACA TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN JERMEI MEDICAL DEVICE TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
THAYER MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
THE RITEDOSE CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
TRUDELL MEDICAL INTERNATIONAL
  SUBSTANTIALLY EQUIVALENT 2
VAPOTHERM, INC.
  SUBSTANTIALLY EQUIVALENT 1
VOLUNTIS
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 185 189
2020 117 117
2021 161 167
2022 55 66
2023 107 108
2024 102 103
2025 196 196

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Deliver 169 169
Connection Problem 56 56
Break 55 55
Leak/Splash 48 48
Defective Device 39 41
Adverse Event Without Identified Device or Use Problem 28 28
Use of Device Problem 26 26
Mechanical Problem 25 25
Therapeutic or Diagnostic Output Failure 24 27
Disconnection 23 23
Insufficient Information 20 20
Fluid/Blood Leak 19 19
Improper Flow or Infusion 17 18
Melted 17 17
Failure to Infuse 16 16
Infusion or Flow Problem 15 15
Output Problem 15 15
Patient Device Interaction Problem 15 15
Defective Component 13 13
Smoking 13 14
Obstruction of Flow 13 23
Fitting Problem 12 12
Fire 12 12
Detachment of Device or Device Component 11 21
Increase in Pressure 11 11
Material Rupture 10 10
Gas/Air Leak 10 10
Component Missing 10 12
Insufficient Flow or Under Infusion 9 10
Loose or Intermittent Connection 9 9
Electrical /Electronic Property Problem 9 9
Failure to Power Up 9 9
Overheating of Device 8 8
Appropriate Term/Code Not Available 8 8
Inaccurate Delivery 7 7
Unexpected Shutdown 7 7
No Flow 7 17
Degraded 6 6
Thermal Decomposition of Device 6 6
Sparking 6 6
Material Integrity Problem 6 6
Incorrect, Inadequate or Imprecise Result or Readings 5 5
Contamination 5 5
Partial Blockage 5 5
Unexpected Therapeutic Results 5 5
Restricted Flow rate 5 5
Improper or Incorrect Procedure or Method 5 5
Temperature Problem 5 5
Protective Measures Problem 4 5
Patient-Device Incompatibility 4 4

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 388 404
No Consequences Or Impact To Patient 149 149
Insufficient Information 133 133
No Known Impact Or Consequence To Patient 59 62
No Patient Involvement 52 52
Low Oxygen Saturation 20 20
Dyspnea 17 18
Unspecified Respiratory Problem 11 13
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 8 8
Aspiration/Inhalation 6 6
Swelling/ Edema 6 6
Dizziness 5 5
Unintended Extubation 5 5
Chronic Obstructive Pulmonary Disease (COPD) 5 5
Respiratory Insufficiency 4 4
No Information 4 4
Pneumonia 4 4
Asthma 4 5
Unspecified Infection 4 4
Headache 3 3
Bacterial Infection 3 3
Hypoxia 3 3
Arrhythmia 3 3
Cough 3 3
Bronchospasm 3 3
Increased Respiratory Rate 3 3
Itching Sensation 3 3
Low Cardiac Output 3 3
Cyanosis 3 3
Loss of consciousness 2 2
Sore Throat 2 2
Urinary Frequency 2 2
Fibrosis 2 2
Airway Obstruction 2 2
Decreased Respiratory Rate 2 2
Pulmonary Edema 2 2
Bradycardia 2 2
Bronchitis 2 2
Chest Pain 2 2
Rash 2 2
Burn(s) 2 2
Sleep Dysfunction 2 3
Pulmonary Hypertension 2 2
Apnea 2 2
Hypersensitivity/Allergic reaction 2 2
Pneumothorax 2 2
Muscle Weakness 2 2
Respiratory Distress 2 2
Pulmonary Emphysema 2 2
High Pulmonary Arterial Wedge Pressure 2 2

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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