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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
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
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 107 107
2024 102 103
2025 168 168

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Deliver 111 111
Break 45 45
Defective Device 33 35
Connection Problem 30 30
Use of Device Problem 25 25
Mechanical Problem 25 25
Adverse Event Without Identified Device or Use Problem 23 23
Leak/Splash 21 21
Therapeutic or Diagnostic Output Failure 20 20
Insufficient Information 19 19
Disconnection 17 17
Melted 17 17
Improper Flow or Infusion 15 16
Patient Device Interaction Problem 15 15
Failure to Infuse 15 15
Obstruction of Flow 13 23
Infusion or Flow Problem 12 12
Fire 12 12
Output Problem 12 12
Smoking 12 12
Increase in Pressure 11 11
Fluid/Blood Leak 10 10
Detachment of Device or Device Component 10 20
Insufficient Flow or Under Infusion 9 10
Component Missing 9 11
Failure to Power Up 9 9
Appropriate Term/Code Not Available 8 8
Defective Component 8 8
Loose or Intermittent Connection 7 7
Unexpected Shutdown 7 7
Gas/Air Leak 6 6
Electrical /Electronic Property Problem 6 6
Overheating of Device 6 6
Material Integrity Problem 6 6
Thermal Decomposition of Device 5 5
Partial Blockage 5 5
Degraded 5 5
Incorrect, Inadequate or Imprecise Result or Readings 5 5
Contamination 5 5
Unexpected Therapeutic Results 5 5
No Flow 5 15
Sparking 5 5
Fitting Problem 5 5
Temperature Problem 5 5
Protective Measures Problem 4 5
Restricted Flow rate 4 4
Product Quality Problem 4 14
Material Too Soft/Flexible 4 4
Charging Problem 4 4
Failure to Charge 4 4

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 372 387
Insufficient Information 126 126
No Consequences Or Impact To Patient 52 52
No Known Impact Or Consequence To Patient 23 23
Low Oxygen Saturation 17 17
Dyspnea 17 18
No Patient Involvement 14 14
Unspecified Respiratory Problem 10 12
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 8 8
Swelling/ Edema 6 6
Aspiration/Inhalation 6 6
Unintended Extubation 5 5
Chronic Obstructive Pulmonary Disease (COPD) 5 5
Respiratory Insufficiency 4 4
Dizziness 4 4
Pneumonia 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
Bronchospasm 3 3
Increased Respiratory Rate 3 3
Itching Sensation 3 3
Bronchitis 2 2
Airway Obstruction 2 2
Fibrosis 2 2
Loss of consciousness 2 2
Sore Throat 2 2
Urinary Frequency 2 2
Pulmonary Edema 2 2
Chest Pain 2 2
Rash 2 2
Burn(s) 2 2
Muscle Weakness 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
Burning Sensation 1 1
Pleural Effusion 1 1
Viral Infection 1 1
Eye Burn 1 1
Pain 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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