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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
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
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 21 21

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Deliver 369 369
Connection Problem 165 165
Leak/Splash 138 138
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
Fluid/Blood Leak 27 27
Improper Flow or Infusion 27 27
Defective Device 26 26
Fire 21 21
Use of Device Problem 20 20
Therapeutic or Diagnostic Output Failure 20 20
Detachment of Device or Device Component 19 19
Mechanical Problem 19 19
Degraded 19 19
Decrease in Pressure 16 16
Insufficient Information 16 16
Output Problem 15 15
Gas/Air Leak 14 14
Overheating of Device 14 14
Material Rupture 14 14
Defective Component 13 13
Peeled/Delaminated 13 13
Smoking 12 12
Adverse Event Without Identified Device or Use Problem 12 12
Patient Device Interaction Problem 11 11
Device Displays Incorrect Message 11 11
Noise, Audible 10 10
Improper or Incorrect Procedure or Method 10 10
Device Emits Odor 10 10
Failure to Power Up 10 10
Component Missing 9 9
Device Inoperable 9 9
Sparking 9 9
Material Integrity Problem 8 8
Loose or Intermittent Connection 8 8
Detachment Of Device Component 8 8
Thermal Decomposition of Device 7 7
Melted 7 7
Restricted Flow rate 7 7
Appropriate Term/Code Not Available 7 7
Charging Problem 6 6
Obstruction of Flow 6 6
Unexpected Shutdown 6 6
Cut In Material 5 5
Temperature Problem 5 5
Manufacturing, Packaging or Shipping Problem 5 5
Air Leak 5 5
Component Falling 5 5
Contamination 5 5
Incorrect, Inadequate or Imprecise Result or Readings 5 5
Product Quality Problem 4 4
Crack 4 4
Burst Container or Vessel 4 4
Battery Problem 4 4
Device Operational Issue 3 3
Failure to Shut Off 3 3
Pressure Problem 3 3
Protective Measures Problem 3 3
Device Markings/Labelling Problem 3 3
Device Contamination with Chemical or Other Material 3 3
Device Alarm System 3 3
Corroded 3 3
Material Frayed 3 3
Display or Visual Feedback Problem 3 3
Kinked 3 3
Off-Label Use 3 3
Material Separation 3 3
Insufficient Flow or Under Infusion 3 3
Device Rinsing Issue 2 2
Incomplete or Missing Packaging 2 2
Sticking 2 2
Device Remains Activated 2 2
Material Too Rigid or Stiff 2 2
Labelling, Instructions for Use or Training Problem 2 2
Insufficient Heating 2 2
No Audible Alarm 2 2
Failure to Charge 2 2
No Pressure 2 2
Maintenance Does Not Comply To Manufacturers Recommendations 2 2
Packaging Problem 2 2
Device Handling Problem 2 2
Electrical Shorting 2 2
Fail-Safe Problem 2 2
Contamination of Device Ingredient or Reagent 2 2
No Device Output 2 2
Device Damaged Prior to Use 2 2
Chemical Problem 2 2
Malposition of Device 2 2
Patient-Device Incompatibility 2 2
Application Program Problem 2 2
Complete Loss of Power 2 2
Separation Problem 2 2
Material Split, Cut or Torn 2 2
Failure to Eject 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 236 236
No Patient Involvement 190 190
Insufficient Information 59 59
No Information 24 24
Low Oxygen Saturation 14 14
Asthma 13 13
No Code Available 12 12
Dyspnea 9 9
Respiratory Distress 8 8
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 8 8
Unspecified Respiratory Problem 7 7
Aspiration/Inhalation 6 6
Burn(s) 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
Hypersensitivity/Allergic reaction 3 3
Apnea 3 3
Sore Throat 3 3
Overdose 3 3
Underdose 3 3
Missed Dose 3 3
Bronchospasm 3 3
Partial thickness (Second Degree) Burn 3 3
Swelling/ Edema 3 3
Cough 2 2
Pulmonary Hypertension 2 2
Respiratory Insufficiency 2 2
Fibrosis 2 2
Sweating 2 2
Urinary Frequency 2 2
Burn, Thermal 2 2
High Pulmonary Arterial Wedge Pressure 2 2
Increased Respiratory Rate 2 2
Hot Flashes/Flushes 2 2
Unspecified Infection 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
Right Ventricular Dysfunction 1 1
Tachycardia 1 1
Tissue Damage 1 1
Visual Disturbances 1 1
Burning Sensation 1 1
Occlusion 1 1
Low Blood Pressure/ Hypotension 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
Reaction 1 1
Complaint, Ill-Defined 1 1
Toxicity 1 1
Injury 1 1
Twitching 1 1
Peeling 1 1
Excessive Tear Production 1 1
Chronic Obstructive Pulmonary Disease (COPD) 1 1
Therapeutic Response, Decreased 1 1
Ulcer 1 1
Ischemic Heart Disease 1 1
Sleep Dysfunction 1 1
Eye Burn 1 1
Respiratory Failure 1 1
Decreased Respiratory Rate 1 1
Chest Tightness/Pressure 1 1
Chemical Exposure 1 1
Ambulation Difficulties 1 1
Electric Shock 1 1
Heart Failure/Congestive Heart Failure 1 1
Superficial (First Degree) Burn 1 1
Wheezing 1 1
Respiratory Arrest 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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