Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
Device nebulizer (direct patient interface)
Product CodeCAF
Regulation Number 868.5630
Device Class 2


Premarket Reviews
ManufacturerDecision
ADHERIUM (NZ) LTD
  SUBSTANTIALLY EQUIVALENT 6
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
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 104 104
2024 21 21

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Deliver 155 155
Connection Problem 55 55
Leak/Splash 43 43
Break 35 35
Disconnection 23 23
Defective Device 18 18
Fluid/Blood Leak 18 18
Use of Device Problem 17 17
Mechanical Problem 16 16
Improper Flow or Infusion 14 14
Output Problem 13 13
Therapeutic or Diagnostic Output Failure 13 13
Fire 12 12
Insufficient Information 11 11
Material Rupture 10 10
Patient Device Interaction Problem 10 10
Infusion or Flow Problem 10 10
Defective Component 10 10
Gas/Air Leak 9 9
Adverse Event Without Identified Device or Use Problem 8 8
Fitting Problem 8 8
Detachment of Device or Device Component 7 7
Electrical /Electronic Property Problem 7 7
No Flow 7 7
Appropriate Term/Code Not Available 7 7
Smoking 6 6
Unexpected Shutdown 6 6
Failure to Power Up 5 5
Overheating of Device 5 5
Incorrect, Inadequate or Imprecise Result or Readings 5 5
Loose or Intermittent Connection 5 5
Component Missing 5 5
Degraded 5 5
Melted 5 5
Sparking 5 5
Contamination 5 5
Product Quality Problem 4 4
Improper or Incorrect Procedure or Method 4 4
Material Integrity Problem 4 4
Inaccurate Delivery 4 4
Insufficient Flow or Under Infusion 3 3
Thermal Decomposition of Device 3 3
Off-Label Use 3 3
Device Emits Odor 3 3
Corroded 3 3
Obstruction of Flow 3 3
Device Displays Incorrect Message 3 3
Material Split, Cut or Torn 2 2
Charging Problem 2 2
Burst Container or Vessel 2 2
Incomplete or Missing Packaging 2 2
Protective Measures Problem 2 2
Device Contamination with Chemical or Other Material 2 2
Pressure Problem 2 2
Electrical Shorting 2 2
Manufacturing, Packaging or Shipping Problem 2 2
Complete Loss of Power 2 2
Malposition of Device 2 2
Separation Problem 2 2
Packaging Problem 2 2
Temperature Problem 2 2
Failure to Shut Off 1 1
Display or Visual Feedback Problem 1 1
Labelling, Instructions for Use or Training Problem 1 1
Noise, Audible 1 1
No Device Output 1 1
Nonstandard Device 1 1
Device Markings/Labelling Problem 1 1
Restricted Flow rate 1 1
Moisture or Humidity Problem 1 1
Mechanics Altered 1 1
Difficult or Delayed Activation 1 1
Incomplete or Inadequate Connection 1 1
Decrease in Pressure 1 1
Physical Resistance/Sticking 1 1
Device-Device Incompatibility 1 1
No Pressure 1 1
Excessive Heating 1 1
Material Too Rigid or Stiff 1 1
Inappropriate Audible Prompt/Feedback 1 1
Material Separation 1 1
Material Fragmentation 1 1
Device Handling Problem 1 1
Component Incompatible 1 1
Material Disintegration 1 1
Fracture 1 1
Difficult to Remove 1 1
Patient-Device Incompatibility 1 1
Material Twisted/Bent 1 1
Communication or Transmission Problem 1 1
Device Ingredient or Reagent Problem 1 1
Power Problem 1 1
Unexpected Therapeutic Results 1 1
Loss of or Failure to Bond 1 1
Failure to Charge 1 1
Incorrect Measurement 1 1
Material Puncture/Hole 1 1
Difficult to Open or Close 1 1
Device Difficult to Setup or Prepare 1 1
Failure to Eject 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 236 236
No Consequences Or Impact To Patient 149 149
No Known Impact Or Consequence To Patient 59 59
Insufficient Information 58 58
No Patient Involvement 52 52
Low Oxygen Saturation 10 10
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 8 8
Dyspnea 8 8
Unspecified Respiratory Problem 7 7
Unintended Extubation 5 5
Aspiration/Inhalation 5 5
No Information 4 4
Swelling/ Edema 3 3
Dizziness 3 3
Asthma 3 3
Pneumothorax 2 2
Itching Sensation 2 2
Headache 2 2
High Pulmonary Arterial Wedge Pressure 2 2
Bronchospasm 2 2
Unspecified Infection 2 2
Respiratory Insufficiency 2 2
Apnea 2 2
Increased Respiratory Rate 2 2
Pulmonary Hypertension 2 2
Bacterial Infection 2 2
Urinary Frequency 2 2
Hypersensitivity/Allergic reaction 2 2
Burn(s) 2 2
Arrhythmia 2 2
Bradycardia 2 2
Cough 2 2
Airway Obstruction 2 2
Sore Throat 2 2
Fibrosis 2 2
Respiratory Distress 2 2
Burning Sensation 1 1
Fatigue 1 1
Decreased Respiratory Rate 1 1
Underdose 1 1
Heart Failure/Congestive Heart Failure 1 1
Ulcer 1 1
Sleep Dysfunction 1 1
Peeling 1 1
No Code Available 1 1
Chemical Exposure 1 1
Hot Flashes/Flushes 1 1
Respiratory Arrest 1 1
Eye Burn 1 1
Death 1 1
Abrasion 1 1
Cyanosis 1 1
Wheezing 1 1
Missed Dose 1 1
Occlusion 1 1
Low Blood Pressure/ Hypotension 1 1
Electric Shock 1 1
Pulmonary Edema 1 1
Hemorrhage/Bleeding 1 1
Right Ventricular Dysfunction 1 1
Skin Inflammation/ Irritation 1 1
Pneumonia 1 1
Chest Pain 1 1
Burn, Thermal 1 1
Rash 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
-
-