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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
  1.  K211233  Hailie Sensor NF0109
  2.  K220622  Hailie Sensor NF0106
  3.  K221994  Hailie Sensor NF0107 & NF0108
  4.  K222247  Hailie Sensor NF0110
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 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 196 196

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Deliver 112 112
Break 53 53
Defective Device 36 38
Connection Problem 31 31
Adverse Event Without Identified Device or Use Problem 25 25
Mechanical Problem 25 25
Use of Device Problem 25 25
Therapeutic or Diagnostic Output Failure 22 22
Leak/Splash 21 21
Insufficient Information 19 19
Disconnection 17 17
Melted 17 17
Failure to Infuse 16 16
Patient Device Interaction Problem 15 15
Improper Flow or Infusion 15 16
Output Problem 14 14
Infusion or Flow Problem 13 13
Smoking 13 14
Obstruction of Flow 13 23
Fire 12 12
Increase in Pressure 11 11
Detachment of Device or Device Component 11 21
Fluid/Blood Leak 11 11
Component Missing 10 12
Failure to Power Up 9 9
Loose or Intermittent Connection 9 9
Defective Component 9 9
Insufficient Flow or Under Infusion 9 10
Appropriate Term/Code Not Available 8 8
Gas/Air Leak 7 7
Unexpected Shutdown 7 7
Overheating of Device 6 6
Electrical /Electronic Property Problem 6 6
Material Integrity Problem 6 6
Fitting Problem 6 6
Partial Blockage 5 5
Restricted Flow rate 5 5
Unexpected Therapeutic Results 5 5
Thermal Decomposition of Device 5 5
No Flow 5 15
Degraded 5 5
Temperature Problem 5 5
Sparking 5 5
Contamination 5 5
Incorrect, Inadequate or Imprecise Result or Readings 5 5
Product Quality Problem 4 14
Charging Problem 4 4
Protective Measures Problem 4 5
Patient-Device Incompatibility 4 4
Material Too Soft/Flexible 4 4

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 388 404
Insufficient Information 133 133
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 11 13
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
Asthma 4 5
Pneumonia 4 4
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
Low Cardiac Output 3 3
Bronchitis 2 2
Decreased Respiratory Rate 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
Sleep Dysfunction 2 3
Pleural Effusion 1 1
Viral Infection 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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