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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 4
AEROGEN, LTD.
  SUBSTANTIALLY EQUIVALENT 1
AIREHEALTH, INC.
  SUBSTANTIALLY EQUIVALENT 1
BREATHESUITE, INC.
  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
  1.  K192971  Nebulizer Kit
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
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 107 107
Infusion or Flow Problem 48 48
Connection Problem 33 33
Leak/Splash 25 25
Adverse Event Without Identified Device or Use Problem 23 23
Use of Device Problem 22 22
Melted 20 20
Disconnection 18 18
Insufficient Device Problem Information 15 15
Mechanical Problem 14 14
Insufficient Heating 14 14
Failure to Infuse 14 14
Smoking 13 14
Obstruction of Flow 12 12
Improper Flow or Infusion 11 11
Loose or Intermittent Connection 11 11
Break 11 11
Increase in Pressure 11 11
Fluid/Blood Leak 10 10
Insufficient Flow or Under Infusion 9 10
Fire 9 9
Overheating of Device 8 8
Defective Device 8 8
Gas/Air Leak 7 7
Failure to Power Up 7 7
Output Problem 6 6
Appropriate Device Problem Term/Code Not Available 6 6
Thermal Decomposition of Device 6 6
Material Integrity Problem 6 6
Unexpected Shutdown 5 5
Electrical /Electronic Property Problem 5 5
No Flow 5 5
Sparking 5 5
Degraded 5 5
Patient Device Interaction Problem 5 5
Detachment of Device or Device Component 4 4
Partial Blockage 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
Defective Component 3 3
Inaccurate Delivery 3 3
Charging Problem 3 3
Material Rupture 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 52 52
No Known Impact Or Consequence To Patient 23 23
Low Oxygen Saturation 19 19
Dyspnea 18 19
Unspecified Respiratory Problem 17 19
No Patient Involvement 14 14
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available 11 11
Swelling/ Edema 6 6
Aspiration/Inhalation 6 6
Unintended Extubation 5 5
Pneumonia 5 5
Chronic Obstructive Pulmonary Disease (COPD) 5 5
Respiratory Insufficiency 4 4
Dizziness 4 4
Bronchospasm 4 4
Asthma 4 5
Cyanosis 3 3
Unspecified Infection 3 3
Arrhythmia 3 3
Headache 3 3
Bacterial Infection 3 3
Hypoxia 3 3
No Information 3 3
Cough 3 3
Increased Respiratory Rate 3 3
Itching Sensation 3 3
Bronchitis 2 2
Decreased Respiratory Rate 2 2
Respiratory Failure 2 2
Airway Obstruction 2 2
Fibrosis 2 2
Loss of consciousness 2 2
Sore Throat 2 2
Pulmonary Edema 2 2
Heart Failure/Congestive Heart Failure 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
High Pulmonary Arterial Wedge Pressure 2 2
Pneumothorax 2 2
Hypersensitivity/Allergic reaction 2 2
Apnea 2 2
Pulmonary Hypertension 2 2
Sleep Dysfunction 2 3
Muscle Weakness/Atrophy 2 2

Recalls
Manufacturer Recall Class Date Posted
1 MEDLINE INDUSTRIES, LP - Northfield I Sep-14-2023
2 Smiths Medical ASD Inc. II Apr-29-2021
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