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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)
Product CodeCAF
Regulation Number 868.5630
Device Class 2


Premarket Reviews
ManufacturerDecision
ADHERIUM (NZ) LTD
  SUBSTANTIALLY EQUIVALENT 6
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
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 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
THAYER MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
THE RITEDOSE CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
TRUDELL MEDICAL INTERNATIONAL
  SUBSTANTIALLY EQUIVALENT 2
VAPOTHERM INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 185 185
2020 117 117
2021 161 161
2022 55 55
2023 105 105
2024 46 46

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Deliver 157 157
Connection Problem 55 55
Leak/Splash 44 44
Break 35 35
Disconnection 23 23
Mechanical Problem 19 19
Fluid/Blood Leak 18 18
Defective Device 18 18
Use of Device Problem 17 17
Improper Flow or Infusion 15 15
Therapeutic or Diagnostic Output Failure 13 13
Output Problem 13 13
Infusion or Flow Problem 12 12
Fire 12 12
Insufficient Information 11 11
Patient Device Interaction Problem 11 11
Adverse Event Without Identified Device or Use Problem 10 10
Defective Component 10 10
Material Rupture 10 10
Gas/Air Leak 9 9
Smoking 8 8
Fitting Problem 8 8
Detachment of Device or Device Component 8 8
Electrical /Electronic Property Problem 7 7
Appropriate Term/Code Not Available 7 7
Overheating of Device 7 7
No Flow 7 7
Unexpected Shutdown 6 6
Loose or Intermittent Connection 6 6
Contamination 5 5
Incorrect, Inadequate or Imprecise Result or Readings 5 5
Sparking 5 5
Insufficient Flow or Under Infusion 5 5
Failure to Power Up 5 5
Degraded 5 5
Melted 5 5
Component Missing 5 5
Product Quality Problem 4 4
Inaccurate Delivery 4 4
Material Integrity Problem 4 4
Improper or Incorrect Procedure or Method 4 4
Thermal Decomposition of Device 3 3
Device Emits Odor 3 3
Obstruction of Flow 3 3
Corroded 3 3
Device Displays Incorrect Message 3 3
Off-Label Use 3 3
Packaging Problem 2 2
Device Contamination with Chemical or Other Material 2 2
Manufacturing, Packaging or Shipping Problem 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 249 249
No Consequences Or Impact To Patient 149 149
Insufficient Information 65 65
No Known Impact Or Consequence To Patient 59 59
No Patient Involvement 52 52
Dyspnea 12 12
Low Oxygen Saturation 12 12
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 8 8
Unspecified Respiratory Problem 7 7
Aspiration/Inhalation 5 5
Unintended Extubation 5 5
No Information 4 4
Swelling/ Edema 4 4
Asthma 3 3
Dizziness 3 3
Headache 3 3
Burn(s) 2 2
Cough 2 2
Respiratory Insufficiency 2 2
Fibrosis 2 2
Urinary Frequency 2 2
Airway Obstruction 2 2
Apnea 2 2
Respiratory Distress 2 2
Cyanosis 2 2
High Pulmonary Arterial Wedge Pressure 2 2
Bradycardia 2 2
Chest Pain 2 2
Hypersensitivity/Allergic reaction 2 2
Bronchospasm 2 2
Pulmonary Hypertension 2 2
Pneumothorax 2 2
Bacterial Infection 2 2
Sore Throat 2 2
Hypoxia 2 2
Unspecified Infection 2 2
Increased Respiratory Rate 2 2
Itching Sensation 2 2
Arrhythmia 2 2
Fatigue 1 1
Abrasion 1 1
Tachycardia 1 1
Eye Burn 1 1
Decreased Respiratory Rate 1 1
Wheezing 1 1
Burn, Thermal 1 1
Death 1 1
Rash 1 1
Occlusion 1 1
Burning Sensation 1 1

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
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