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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, 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 2
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 184 184

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Deliver 112 112
Break 49 49
Defective Device 36 38
Connection Problem 31 31
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 21 21
Insufficient Information 19 19
Disconnection 17 17
Melted 17 17
Failure to Infuse 16 16
Improper Flow or Infusion 15 16
Patient Device Interaction Problem 15 15
Infusion or Flow Problem 13 13
Obstruction of Flow 13 23
Output Problem 13 13
Fire 12 12
Smoking 12 13
Fluid/Blood Leak 11 11
Detachment of Device or Device Component 11 21
Increase in Pressure 11 11
Component Missing 10 12
Insufficient Flow or Under Infusion 9 10
Failure to Power Up 9 9
Defective Component 9 9
Loose or Intermittent Connection 8 8
Appropriate Term/Code Not Available 8 8
Gas/Air Leak 7 7
Unexpected Shutdown 7 7
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
Restricted Flow rate 5 5
No Flow 5 15
Temperature Problem 5 5
Sparking 5 5
Fitting Problem 5 5
Protective Measures Problem 4 5
Material Too Soft/Flexible 4 4
Product Quality Problem 4 14
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 383 399
Insufficient Information 130 130
No Consequences Or Impact To Patient 52 52
No Known Impact Or Consequence To Patient 23 23
Low Oxygen Saturation 18 18
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
Unspecified Infection 3 3
Cyanosis 3 3
Arrhythmia 3 3
Headache 3 3
Bacterial Infection 3 3
Hypoxia 3 3
No Information 3 3
Bronchospasm 3 3
Increased Respiratory Rate 3 3
Cough 3 3
Itching Sensation 3 3
Bronchitis 2 2
Airway Obstruction 2 2
Loss of consciousness 2 2
Sore Throat 2 2
Urinary Frequency 2 2
Fibrosis 2 2
Pulmonary Edema 2 2
Chest Pain 2 2
Rash 2 2
Burn(s) 2 2
Pulmonary Emphysema 2 2
Muscle Weakness 2 2
High Pulmonary Arterial Wedge Pressure 2 2
Hypersensitivity/Allergic reaction 2 2
Pneumothorax 2 2
Apnea 2 2
Pulmonary Hypertension 2 2
Burning Sensation 1 1
Viral Infection 1 1
Pleural Effusion 1 1
Eye Burn 1 1
Peeling 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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