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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 9
AEROGEN, LTD.
  SUBSTANTIALLY EQUIVALENT 1
AIREHEALTH, INC.
  SUBSTANTIALLY EQUIVALENT 1
BREATHESUITE, INC.
  SUBSTANTIALLY EQUIVALENT 1
COGNITA LABS, LLC
  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
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
  1.  K230602  Hudson RCI® TurboMist™ Nebulizer System
  2.  K231058  Hudson RCI® AddiPak® Unit Dose Vial
MICROBASE TECHNOLOGY CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
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 2
RECIPROCAL LABS CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
SHENZHEN HOMED MEDICAL DEVICE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
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 4
VAPOTHERM, INC.
  SUBSTANTIALLY EQUIVALENT 1
VOLUNTIS
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2018 162 162
2019 185 189
2020 117 117
2021 161 167
2022 55 66
2023 107 108
2024 102 103
2025 193 193
2026 133 133

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Deliver 206 206
Break 76 76
Leak/Splash 72 72
Connection Problem 72 72
Defective Device 58 60
Disconnection 47 47
Infusion or Flow Problem 47 47
Therapeutic or Diagnostic Output Failure 37 40
Adverse Event Without Identified Device or Use Problem 33 33
Use of Device Problem 31 31
Mechanical Problem 29 29
Fitting Problem 28 28
Fluid/Blood Leak 28 28
Output Problem 23 23
Insufficient Information 22 22
Electrical /Electronic Property Problem 19 19
Improper Flow or Infusion 19 20
Gas/Air Leak 18 18
Melted 17 17
Obstruction of Flow 17 27
Patient Device Interaction Problem 17 17
Failure to Infuse 16 16
Detachment of Device or Device Component 16 26
No Flow 15 25
Defective Component 15 15
Material Rupture 14 14
Smoking 14 15
Insufficient Heating 13 13
Fire 13 13
Loose or Intermittent Connection 13 13
Increase in Pressure 11 11
Component Missing 11 13
Inaccurate Delivery 10 10
Overheating of Device 10 10
Failure to Power Up 10 10
Insufficient Flow or Under Infusion 9 10
Appropriate Term/Code Not Available 8 8
Unexpected Shutdown 8 8
Degraded 8 8
Noise, Audible 8 8
Material Integrity Problem 8 8
Thermal Decomposition of Device 6 6
Improper or Incorrect Procedure or Method 6 6
Sparking 6 6
Unexpected Therapeutic Results 5 5
Partial Blockage 5 5
Charging Problem 5 5
Incorrect, Inadequate or Imprecise Result or Readings 5 5
Temperature Problem 5 5
Contamination 5 5

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 487 503
No Consequences Or Impact To Patient 231 231
Insufficient Information 161 161
No Known Impact Or Consequence To Patient 93 96
No Patient Involvement 80 80
Low Oxygen Saturation 21 21
Dyspnea 18 19
Unspecified Respiratory Problem 12 14
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 8 8
No Information 8 8
Pneumonia 6 6
Respiratory Distress 6 6
Aspiration/Inhalation 6 6
Swelling/ Edema 6 6
Unintended Extubation 5 5
Chronic Obstructive Pulmonary Disease (COPD) 5 5
Asthma 5 6
Bronchospasm 5 5
Dizziness 5 5
Unspecified Infection 4 4
Respiratory Insufficiency 4 4
Itching Sensation 3 3
Increased Respiratory Rate 3 3
Cough 3 3
Hypoxia 3 3
Bacterial Infection 3 3
Headache 3 3
No Code Available 3 3
Arrhythmia 3 3
Apnea 3 3
Cyanosis 3 3
Urinary Frequency 2 2
Sore Throat 2 2
Loss of consciousness 2 2
Pulmonary Edema 2 2
Heart Failure/Congestive Heart Failure 2 2
Fibrosis 2 2
Airway Obstruction 2 2
Bradycardia 2 2
Cardiopulmonary Arrest 2 2
Respiratory Failure 2 2
Decreased Respiratory Rate 2 2
Bronchitis 2 2
Viral Infection 2 2
Chest Pain 2 2
Sleep Dysfunction 2 3
Rash 2 2
Burn(s) 2 2
Pulmonary Hypertension 2 2
Death 2 2

Recalls
Manufacturer Recall Class Date Posted
1 MEDLINE INDUSTRIES, LP - Northfield I Sep-14-2023
2 Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company I Feb-04-2019
3 SANRAI INTERNATIONAL LLC II Mar-26-2019
4 Smiths Medical ASD Inc. II Apr-29-2021
5 Valeant Pharmacueticals International II Jan-17-2018
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