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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
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 2
JOYTECH HEALTHCARE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
MANKIND PHARMA LIMITED
  SUBSTANTIALLY EQUIVALENT 1
  1.  K232523  Sodium Chloride Inhalation Solution, USP 0.9%, 3% ...
MEDLINE INDUSTIRES, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDLINE INDUSTRIES LP
  SUBSTANTIALLY EQUIVALENT 1
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
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 161 161
2022 55 55
2023 107 107
2024 102 103
2025 89 89

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Deliver 110 110
Break 33 33
Connection Problem 30 30
Use of Device Problem 25 25
Defective Device 23 23
Mechanical Problem 22 22
Adverse Event Without Identified Device or Use Problem 19 19
Leak/Splash 18 18
Insufficient Information 18 18
Disconnection 17 17
Melted 15 15
Failure to Infuse 14 14
Improper Flow or Infusion 13 13
Therapeutic or Diagnostic Output Failure 13 13
Fire 12 12
Output Problem 12 12
Smoking 12 12
Infusion or Flow Problem 11 11
Patient Device Interaction Problem 11 11
Fluid/Blood Leak 10 10
Insufficient Flow or Under Infusion 9 10
Failure to Power Up 8 8
Appropriate Term/Code Not Available 8 8
Detachment of Device or Device Component 8 8
Gas/Air Leak 6 6
Component Missing 6 6
Loose or Intermittent Connection 6 6
Electrical /Electronic Property Problem 6 6
Unexpected Shutdown 6 6
Overheating of Device 6 6
Defective Component 6 6
Thermal Decomposition of Device 5 5
Degraded 5 5
Incorrect, Inadequate or Imprecise Result or Readings 5 5
Contamination 5 5
Material Integrity Problem 5 5
No Flow 5 5
Temperature Problem 5 5
Product Quality Problem 4 4
Restricted Flow rate 4 4
Partial Blockage 4 4
Unexpected Therapeutic Results 4 4
Material Too Soft/Flexible 4 4
Sparking 4 4
Failure to Charge 4 4
Manufacturing, Packaging or Shipping Problem 3 3
Device Emits Odor 3 3
Inaccurate Delivery 3 3
Material Rupture 3 3
Pressure Problem 3 3

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 344 345
Insufficient Information 91 91
No Consequences Or Impact To Patient 52 52
No Known Impact Or Consequence To Patient 23 23
Low Oxygen Saturation 16 16
Dyspnea 15 15
No Patient Involvement 14 14
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 8 8
Unspecified Respiratory Problem 8 8
Swelling/ Edema 6 6
Aspiration/Inhalation 6 6
Unintended Extubation 5 5
Respiratory Insufficiency 4 4
Dizziness 4 4
Chronic Obstructive Pulmonary Disease (COPD) 4 4
Cyanosis 3 3
Arrhythmia 3 3
Headache 3 3
Bacterial Infection 3 3
No Information 3 3
Increased Respiratory Rate 3 3
Asthma 3 3
Itching Sensation 3 3
Airway Obstruction 2 2
Sore Throat 2 2
Urinary Frequency 2 2
Fibrosis 2 2
Hypoxia 2 2
Bronchospasm 2 2
Cough 2 2
Pneumonia 2 2
Chest Pain 2 2
Rash 2 2
Burn(s) 2 2
Muscle Weakness 2 2
High Pulmonary Arterial Wedge Pressure 2 2
Hypersensitivity/Allergic reaction 2 2
Pneumothorax 2 2
Apnea 2 2
Unspecified Infection 2 2
Pulmonary Hypertension 2 2
Burning Sensation 1 1
Eye Burn 1 1
Acanthameba Keratitis 1 1
Viral Infection 1 1
Malaise 1 1
Peeling 1 1
Pain 1 1
Bradycardia 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 Smiths Medical ASD Inc. II Apr-29-2021
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