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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 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
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
MICROBASE TECHNOLOGY CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
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 2
SHENZHEN HOMED MEDICAL DEVICE CO,.LTD.
  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
  1.  K233553  MiniSpacer® 1024, 1025, 1543 and 1024A, 1025A, 154 ...
THE RITEDOSE CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
TRUDELL MEDICAL INTERNATIONAL
  SUBSTANTIALLY EQUIVALENT 4
VAPOTHERM INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2018 162 162
2019 185 185
2020 117 117
2021 161 161
2022 55 55
2023 107 107
2024 76 77

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Deliver 190 190
Connection Problem 70 70
Leak/Splash 63 63
Disconnection 46 46
Break 40 40
Fluid/Blood Leak 23 23
Fitting Problem 23 23
Mechanical Problem 21 21
Defective Device 19 19
Improper Flow or Infusion 17 17
Electrical /Electronic Property Problem 17 17
Use of Device Problem 17 17
Output Problem 15 15
Infusion or Flow Problem 15 15
Failure to Infuse 14 14
Material Rupture 14 14
Gas/Air Leak 14 14
Fire 13 13
Insufficient Information 13 13
No Flow 13 13
Therapeutic or Diagnostic Output Failure 13 13
Patient Device Interaction Problem 12 12
Detachment of Device or Device Component 12 12
Adverse Event Without Identified Device or Use Problem 11 11
Defective Component 11 11
Melted 10 10
Overheating of Device 8 8
Inaccurate Delivery 8 8
Smoking 8 8
Degraded 7 7
Loose or Intermittent Connection 7 7
Appropriate Term/Code Not Available 7 7
Unexpected Shutdown 6 6
Obstruction of Flow 6 6
Insufficient Flow or Under Infusion 6 7
Failure to Power Up 6 6
Improper or Incorrect Procedure or Method 5 5
Component Missing 5 5
Sparking 5 5
Incorrect, Inadequate or Imprecise Result or Readings 5 5
Contamination 5 5
Material Integrity Problem 5 5
Product Quality Problem 4 4
Device Operates Differently Than Expected 4 4
Thermal Decomposition of Device 3 3
Charging Problem 3 3
Partial Blockage 3 3
Device Emits Odor 3 3
Corroded 3 3
Display or Visual Feedback Problem 3 3

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 273 274
No Consequences Or Impact To Patient 231 231
No Known Impact Or Consequence To Patient 93 93
No Patient Involvement 80 80
Insufficient Information 71 71
Low Oxygen Saturation 12 12
Dyspnea 12 12
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 8 8
No Information 8 8
Unspecified Respiratory Problem 7 7
Respiratory Distress 6 6
Unintended Extubation 5 5
Aspiration/Inhalation 5 5
Swelling/ Edema 4 4
Asthma 4 4
Apnea 3 3
Headache 3 3
No Code Available 3 3
Bronchospasm 3 3
Increased Respiratory Rate 3 3
Dizziness 3 3
Pneumonia 3 3
Airway Obstruction 2 2
Respiratory Insufficiency 2 2
Fibrosis 2 2
Sore Throat 2 2
Urinary Frequency 2 2
Bacterial Infection 2 2
Hypoxia 2 2
Cough 2 2
Bradycardia 2 2
Cardiopulmonary Arrest 2 2
Chest Pain 2 2
Burn(s) 2 2
Itching Sensation 2 2
High Pulmonary Arterial Wedge Pressure 2 2
Pneumothorax 2 2
Hypersensitivity/Allergic reaction 2 2
Death 2 2
Arrhythmia 2 2
Pulmonary Hypertension 2 2
Unspecified Infection 2 2
Cyanosis 2 2
Right Ventricular Dysfunction 1 1
Rash 1 1
Burning Sensation 1 1
Chemical Exposure 1 1
Burn, Thermal 1 1
Eye Burn 1 1
Abrasion 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
5 Valeant Pharmacueticals International II Jan-17-2018
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