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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
FINDAIR SP. Z O.O.
  SUBSTANTIALLY EQUIVALENT 1
FISHER & PAYKEL HEALTHCARE LIMITED
  SUBSTANTIALLY EQUIVALENT 1
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 193 193
2026 201 201

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Deliver 163 163
Connection Problem 58 58
Infusion or Flow Problem 50 50
Leak/Splash 49 49
Disconnection 24 24
Adverse Event Without Identified Device or Use Problem 23 23
Use of Device Problem 22 22
Melted 20 20
Fluid/Blood Leak 17 17
Insufficient Device Problem Information 16 16
Mechanical Problem 14 14
Insufficient Heating 14 14
Failure to Infuse 14 14
Break 13 13
Smoking 13 14
Obstruction of Flow 12 12
Improper Flow or Infusion 12 12
Loose or Intermittent Connection 11 11
Increase in Pressure 11 11
Gas/Air Leak 10 10
Material Rupture 10 10
Overheating of Device 9 9
Fire 9 9
Defective Device 9 9
Insufficient Flow or Under Infusion 9 10
Fitting Problem 8 8
Electrical /Electronic Property Problem 8 8
Failure to Power Up 7 7
Thermal Decomposition of Device 7 7
Appropriate Device Problem Term/Code Not Available 6 6
Inaccurate Delivery 6 6
Output Problem 6 6
Material Integrity Problem 6 6
No Flow 6 6
Sparking 6 6
Degraded 6 6
Defective Component 5 5
Unexpected Shutdown 5 5
Patient Device Interaction Problem 5 5
Partial Blockage 4 4
Detachment of Device or Device Component 4 4
Unexpected Therapeutic Results 4 4
Material Too Soft/Flexible 4 4
No Device Output 4 4
Temperature Problem 4 4
Restricted Flow rate 4 4
Contamination /Decontamination Problem 3 3
Component Missing 3 3
Contamination 3 3
Therapeutic or Diagnostic Output Failure 3 3

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 539 555
Insufficient Information 171 171
No Consequences Or Impact To Patient 149 149
No Known Impact Or Consequence To Patient 59 62
No Patient Involvement 52 52
Low Oxygen Saturation 21 21
Dyspnea 18 19
Unspecified Respiratory Problem 17 19
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available 11 11
Swelling/ Edema 6 6
Aspiration/Inhalation 6 6
Pneumonia 5 5
Unintended Extubation 5 5
Dizziness 5 5
Chronic Obstructive Pulmonary Disease (COPD) 5 5
Unspecified Infection 4 4
Bronchospasm 4 4
Respiratory Insufficiency 4 4
No Information 4 4
Asthma 4 5
Cyanosis 3 3
Increased Respiratory Rate 3 3
Arrhythmia 3 3
Cough 3 3
Hypoxia 3 3
Headache 3 3
Itching Sensation 3 3
Bacterial Infection 3 3
Heart Failure/Congestive Heart Failure 2 2
Bradycardia 2 2
Pulmonary Edema 2 2
Viral Infection 2 2
Chest Pain 2 2
Rash 2 2
Burn(s) 2 2
Urinary Frequency / Polyuria 2 2
Pulmonary Emphysema 2 2
Sore Throat 2 2
Loss of consciousness 2 2
Fibrosis 2 2
Airway Obstruction 2 2
High Pulmonary Arterial Wedge Pressure 2 2
Respiratory Distress 2 2
Respiratory Failure 2 2
Decreased Respiratory Rate 2 2
Pneumothorax 2 2
Hypersensitivity/Allergic reaction 2 2
Apnea 2 2
Bronchitis 2 2
Pulmonary Hypertension 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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