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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
ACTIVAERO AMERICA, INC.
  SUBSTANTIALLY EQUIVALENT 1
ADHERIUM (NZ) LTD
  SUBSTANTIALLY EQUIVALENT 10
AEROGEN IRELAND, LTD.
  SUBSTANTIALLY EQUIVALENT 1
AEROGEN LIMITED
  SUBSTANTIALLY EQUIVALENT 1
AEROGEN LTD
  SUBSTANTIALLY EQUIVALENT 3
AEROGEN LTD.
  SUBSTANTIALLY EQUIVALENT 1
AIREHEALTH INC.
  SUBSTANTIALLY EQUIVALENT 1
ARMSTRONG MEDICAL LTD.
  SUBSTANTIALLY EQUIVALENT 1
ATLANTEAN CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
BESMED HEALTH BUSINESS CORP.
  SUBSTANTIALLY EQUIVALENT 2
BREATHESUITE INC
  SUBSTANTIALLY EQUIVALENT 1
CAREFUSION
  SUBSTANTIALLY EQUIVALENT 2
COGNITA LABS, LLC
  SUBSTANTIALLY EQUIVALENT 1
CONVEXITY SCIENTIFIC LLC
  SUBSTANTIALLY EQUIVALENT 1
DIAGNOSTIC DEVICES, INC.
  SUBSTANTIALLY EQUIVALENT 1
DIGIO2 INTERNATIONAL CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
DONGGUAN AIDISY MACHINERY & ELECTRONIC EQUIPMENT C
  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
FOSHAN CARE MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
FOSHAN GAUNYING ELECTRONICS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3
GLOBALCARE MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
HCMED INNOVATIONS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
HEADSTAR MEDICAL PRODUCTS CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
INSTRUMENTATION INDUSTRIES, INC.
  SUBSTANTIALLY EQUIVALENT 3
K-JUMP HEALTH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
KOO(SHANGHAI)INDUSTRIES 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
MERITS HEALTH PRODUCTS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
MICROBASE TECHNOLOGY CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
MICROVAPER DEVICES
  SUBSTANTIALLY EQUIVALENT 1
MONAGHAN MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
NEPHRON PHARMACEUTICALS CORP.
  SUBSTANTIALLY EQUIVALENT 2
NEXUS6, LTD.
  SUBSTANTIALLY EQUIVALENT 2
OCHSNER CLINIC FOUNDATION
  SUBSTANTIALLY EQUIVALENT 1
ODYSSEY MEDICAL TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 1
OMRON HEALTHCARE, INC.
  SUBSTANTIALLY EQUIVALENT 2
  1.  K110860  COMP A-I-R
  2.  K141140  COMP A-I-R
PARI RESPIRATORY EQUIPMENT, INC.
  SUBSTANTIALLY EQUIVALENT 7
PEGASUS RESEARCH CORP.
  SUBSTANTIALLY EQUIVALENT 1
PHARMACARIBE
  SUBSTANTIALLY EQUIVALENT 2
QINGDAO FUTURE MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
QUALITY LIFE TECHNOLOGIES CO;LTD
  SUBSTANTIALLY EQUIVALENT 1
RECIPROCAL LABS
  SUBSTANTIALLY EQUIVALENT 4
RECIPROCAL LABS CORPORATION
  SUBSTANTIALLY EQUIVALENT 6
RESPIRONICS NEW JERSEY, INC.
  SUBSTANTIALLY EQUIVALENT 1
RESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTD.
  SUBSTANTIALLY EQUIVALENT 2
ROLLINS MEDICAL SOLUTIONS, INC.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN HOMED MEDICAL DEVICE CO,.LTD.
  SUBSTANTIALLY EQUIVALENT 1
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
SOUTHMEDIC, INC.
  SUBSTANTIALLY EQUIVALENT 1
STEVE ISLAVA
  SUBSTANTIALLY EQUIVALENT 1
SUZHOU WEIKANG MEDICAL APPARATUS CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
TAIDOC TECHNOLOGY CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
TELEFLEX MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 3
THAYER MEDICAL CORP.
  SUBSTANTIALLY EQUIVALENT 1
THAYER MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
THE RITEDOSE CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
TRUDELL MEDICAL INT'L
  SUBSTANTIALLY EQUIVALENT 1
TRUDELL MEDICAL INTERNATIONAL
  SUBSTANTIALLY EQUIVALENT 4
TRUDELL MEDICAL INTL.
  SUBSTANTIALLY EQUIVALENT 2
VAPOTHERM INC.
  SUBSTANTIALLY EQUIVALENT 1
VECTURA GMBH
  SUBSTANTIALLY EQUIVALENT 1
VENTLAB CORP.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 122 122
2015 166 166
2016 201 201
2017 256 256
2018 162 162
2019 185 185
2020 117 117
2021 161 161
2022 55 55
2023 104 104
2024 30 30

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Deliver 369 369
Connection Problem 165 165
Leak/Splash 139 139
Infusion or Flow Problem 93 93
Break 79 79
Disconnection 70 70
No Flow 68 68
Device Operates Differently Than Expected 46 46
Fitting Problem 46 46
Inaccurate Delivery 43 43
Electrical /Electronic Property Problem 32 32
Improper Flow or Infusion 28 28
Fluid/Blood Leak 27 27
Defective Device 26 26
Fire 21 21
Therapeutic or Diagnostic Output Failure 20 20
Use of Device Problem 20 20
Degraded 19 19
Detachment of Device or Device Component 19 19
Mechanical Problem 19 19
Decrease in Pressure 17 17
Insufficient Information 16 16
Output Problem 15 15
Overheating of Device 14 14
Material Rupture 14 14
Gas/Air Leak 14 14
Defective Component 13 13
Smoking 13 13
Peeled/Delaminated 13 13
Patient Device Interaction Problem 12 12
Adverse Event Without Identified Device or Use Problem 12 12
Device Displays Incorrect Message 11 11
Improper or Incorrect Procedure or Method 10 10
Failure to Power Up 10 10
Device Emits Odor 10 10
Noise, Audible 10 10
Device Inoperable 9 9
Sparking 9 9
Component Missing 9 9
Material Integrity Problem 8 8
Loose or Intermittent Connection 8 8
Detachment Of Device Component 8 8
Restricted Flow rate 7 7
Thermal Decomposition of Device 7 7
Melted 7 7
Appropriate Term/Code Not Available 7 7
Obstruction of Flow 6 6
Charging Problem 6 6
Unexpected Shutdown 6 6
Air Leak 5 5
Component Falling 5 5
Manufacturing, Packaging or Shipping Problem 5 5
Temperature Problem 5 5
Incorrect, Inadequate or Imprecise Result or Readings 5 5
Cut In Material 5 5
Contamination 5 5
Product Quality Problem 4 4
Battery Problem 4 4
Burst Container or Vessel 4 4
Crack 4 4
Display or Visual Feedback Problem 3 3
Failure to Shut Off 3 3
Insufficient Flow or Under Infusion 3 3
Kinked 3 3
Device Markings/Labelling Problem 3 3
Device Alarm System 3 3
Protective Measures Problem 3 3
Material Separation 3 3
Off-Label Use 3 3
Device Contamination with Chemical or Other Material 3 3
Pressure Problem 3 3
Device Operational Issue 3 3
Corroded 3 3
Material Frayed 3 3
Device Remains Activated 2 2
Fail-Safe Problem 2 2
Insufficient Heating 2 2
Chemical Problem 2 2
No Audible Alarm 2 2
Failure to Charge 2 2
Material Split, Cut or Torn 2 2
Maintenance Does Not Comply To Manufacturers Recommendations 2 2
Patient-Device Incompatibility 2 2
Electrical Shorting 2 2
Contamination of Device Ingredient or Reagent 2 2
Sticking 2 2
No Pressure 2 2
Device Handling Problem 2 2
Material Too Rigid or Stiff 2 2
Incomplete or Missing Packaging 2 2
Application Program Problem 2 2
Device Rinsing Issue 2 2
Device Damaged Prior to Use 2 2
Complete Loss of Power 2 2
Malposition of Device 2 2
No Device Output 2 2
Packaging Problem 2 2
Separation Problem 2 2
Labelling, Instructions for Use or Training Problem 2 2
Filtration Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 587 587
No Known Impact Or Consequence To Patient 358 358
No Clinical Signs, Symptoms or Conditions 240 240
No Patient Involvement 190 190
Insufficient Information 61 61
No Information 24 24
Low Oxygen Saturation 16 16
Asthma 13 13
No Code Available 12 12
Dyspnea 11 11
Respiratory Distress 8 8
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 8 8
Unspecified Respiratory Problem 7 7
Burn(s) 6 6
Aspiration/Inhalation 6 6
Death 5 5
Anxiety 5 5
Dizziness 5 5
Unintended Extubation 5 5
Patient Problem/Medical Problem 4 4
Headache 4 4
Itching Sensation 4 4
Pneumonia 4 4
Overdose 3 3
Hypersensitivity/Allergic reaction 3 3
Apnea 3 3
Sore Throat 3 3
Bronchospasm 3 3
Underdose 3 3
Missed Dose 3 3
Partial thickness (Second Degree) Burn 3 3
Swelling/ Edema 3 3
Fibrosis 2 2
Cough 2 2
Pulmonary Hypertension 2 2
Respiratory Insufficiency 2 2
Unspecified Infection 2 2
High Pulmonary Arterial Wedge Pressure 2 2
Increased Respiratory Rate 2 2
Sweating 2 2
Urinary Frequency 2 2
Burn, Thermal 2 2
Hot Flashes/Flushes 2 2
Tachycardia 2 2
Arrhythmia 2 2
Abrasion 2 2
Airway Obstruction 2 2
Bacterial Infection 2 2
Bradycardia 2 2
Cardiopulmonary Arrest 2 2
Chest Pain 2 2
High Blood Pressure/ Hypertension 2 2
Laceration(s) 2 2
Pneumothorax 2 2
Pulmonary Edema 1 1
Rash 1 1
Occlusion 1 1
Peeling 1 1
Low Blood Pressure/ Hypotension 1 1
Hypoxia 1 1
Hemorrhage/Bleeding 1 1
Cyanosis 1 1
Cardiac Arrest 1 1
Electrocution 1 1
Fatigue 1 1
Fever 1 1
Bronchitis 1 1
Tissue Damage 1 1
Visual Disturbances 1 1
Burning Sensation 1 1
Twitching 1 1
Right Ventricular Dysfunction 1 1
Complaint, Ill-Defined 1 1
Toxicity 1 1
Injury 1 1
Excessive Tear Production 1 1
Chronic Obstructive Pulmonary Disease (COPD) 1 1
Therapeutic Response, Decreased 1 1
Ulcer 1 1
Chest Tightness/Pressure 1 1
Ischemic Heart Disease 1 1
Sleep Dysfunction 1 1
Eye Burn 1 1
Respiratory Failure 1 1
Decreased Respiratory Rate 1 1
Reaction 1 1
Wheezing 1 1
Respiratory Arrest 1 1
Heart Failure/Congestive Heart Failure 1 1
Chemical Exposure 1 1
Ambulation Difficulties 1 1
Electric Shock 1 1
Superficial (First Degree) Burn 1 1
Skin Inflammation/ Irritation 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Aerogen Ltd. II Oct-23-2014
2 Carefusion 211 Inc II Aug-12-2011
3 Compass Health Brands II Jun-06-2015
4 MEDLINE INDUSTRIES, LP - Northfield I Sep-14-2023
5 Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company I Feb-04-2019
6 Nephron Pharmaceuticals Corp. II Jun-27-2016
7 Pharmacaribe llc II Feb-10-2016
8 SANRAI INTERNATIONAL LLC II Mar-26-2019
9 Salter Labs II Feb-10-2016
10 Salter Labs II Sep-17-2015
11 Smiths Medical ASD Inc. II Apr-29-2021
12 Teleflex Medical II Dec-12-2014
13 Thayer Medical Corporation II Feb-07-2017
14 Thayer Medical Corporation II Jul-02-2012
15 Valeant Pharmaceuticals North America LLC II Dec-04-2015
16 Valeant Pharmacueticals International II Jan-17-2018
17 Valeant Pharmacueticals International II Jan-21-2016
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