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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
  1.  K203155  BreatheSuite MDI V1
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
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 104 104
2024 37 37

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
Use of Device Problem 17 17
Electrical /Electronic Property Problem 17 17
Improper Flow or Infusion 17 17
Output Problem 15 15
Infusion or Flow Problem 14 14
Gas/Air Leak 14 14
Material Rupture 14 14
Fire 13 13
No Flow 13 13
Therapeutic or Diagnostic Output Failure 13 13
Insufficient Information 13 13
Patient Device Interaction Problem 12 12
Detachment of Device or Device Component 11 11
Defective Component 11 11
Adverse Event Without Identified Device or Use Problem 9 9
Appropriate Term/Code Not Available 7 7
Smoking 7 7
Degraded 7 7
Loose or Intermittent Connection 6 6
Overheating of Device 6 6
Failure to Power Up 6 6
Inaccurate Delivery 6 6
Obstruction of Flow 6 6
Unexpected Shutdown 6 6
Material Integrity Problem 5 5
Sparking 5 5
Improper or Incorrect Procedure or Method 5 5
Component Missing 5 5
Incorrect, Inadequate or Imprecise Result or Readings 5 5
Melted 5 5
Contamination 5 5
Product Quality Problem 4 4
Insufficient Flow or Under Infusion 4 4
Device Operates Differently Than Expected 4 4
Manufacturing, Packaging or Shipping Problem 3 3
Noise, Audible 3 3
Off-Label Use 3 3
Device Displays Incorrect Message 3 3
Charging Problem 3 3
Corroded 3 3
Display or Visual Feedback Problem 3 3
Thermal Decomposition of Device 3 3
Device Emits Odor 3 3
Burst Container or Vessel 2 2
Detachment Of Device Component 2 2
Malposition of Device 2 2
Incomplete or Missing Packaging 2 2
Decrease in Pressure 2 2
Material Split, Cut or Torn 2 2
Packaging Problem 2 2
Pressure Problem 2 2
Protective Measures Problem 2 2
Temperature Problem 2 2
No Pressure 2 2
Electrical Shorting 2 2
Failure to Shut Off 2 2
Device Contamination with Chemical or Other Material 2 2
Complete Loss of Power 2 2
Separation Problem 2 2
Excessive Heating 1 1
Incomplete or Inadequate Connection 1 1
Human-Device Interface Problem 1 1
Device-Device Incompatibility 1 1
Difficult to Open or Close 1 1
Device Ingredient or Reagent Problem 1 1
Device Markings/Labelling Problem 1 1
Material Twisted/Bent 1 1
Mechanics Altered 1 1
Moisture or Humidity Problem 1 1
Power Problem 1 1
Device Handling Problem 1 1
Activation Failure 1 1
Failure to Eject 1 1
Physical Resistance/Sticking 1 1
Device Fell 1 1
Explosion 1 1
Inappropriate Audible Prompt/Feedback 1 1
Device Damaged Prior to Use 1 1
Unexpected Therapeutic Results 1 1
Unstable 1 1
Material Puncture/Hole 1 1
Difficult to Remove 1 1
Material Too Rigid or Stiff 1 1
Material Separation 1 1
Patient-Device Incompatibility 1 1
Battery Problem 1 1
Difficult or Delayed Activation 1 1
Chemical Problem 1 1
Contamination /Decontamination Problem 1 1
Communication or Transmission Problem 1 1
Contamination of Device Ingredient or Reagent 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 244 244
No Consequences Or Impact To Patient 231 231
No Known Impact Or Consequence To Patient 93 93
No Patient Involvement 80 80
Insufficient Information 61 61
Low Oxygen Saturation 12 12
Dyspnea 11 11
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 8 8
No Information 8 8
Unspecified Respiratory Problem 7 7
Respiratory Distress 6 6
Aspiration/Inhalation 5 5
Unintended Extubation 5 5
Swelling/ Edema 4 4
Asthma 4 4
Headache 3 3
Apnea 3 3
No Code Available 3 3
Dizziness 3 3
Bronchospasm 3 3
High Pulmonary Arterial Wedge Pressure 2 2
Urinary Frequency 2 2
Sore Throat 2 2
Increased Respiratory Rate 2 2
Fibrosis 2 2
Cough 2 2
Pulmonary Hypertension 2 2
Respiratory Insufficiency 2 2
Arrhythmia 2 2
Airway Obstruction 2 2
Bacterial Infection 2 2
Bradycardia 2 2
Burn(s) 2 2
Cardiopulmonary Arrest 2 2
Chest Pain 2 2
Cyanosis 2 2
Death 2 2
Hypersensitivity/Allergic reaction 2 2
Hypoxia 2 2
Unspecified Infection 2 2
Itching Sensation 2 2
Pneumonia 2 2
Pneumothorax 2 2
Pulmonary Edema 1 1
Rash 1 1
Laceration(s) 1 1
Occlusion 1 1
Peeling 1 1
Low Blood Pressure/ Hypotension 1 1
Ulcer 1 1
Right Ventricular Dysfunction 1 1
Tachycardia 1 1
Burning Sensation 1 1
Hot Flashes/Flushes 1 1
Abrasion 1 1
Hemorrhage/Bleeding 1 1
Fatigue 1 1
Wheezing 1 1
Respiratory Arrest 1 1
Heart Failure/Congestive Heart Failure 1 1
Skin Inflammation/ Irritation 1 1
Sleep Dysfunction 1 1
Eye Burn 1 1
Burn, Thermal 1 1
Underdose 1 1
Electric Shock 1 1
Missed Dose 1 1
Chemical Exposure 1 1
Decreased Respiratory Rate 1 1
Superficial (First Degree) Burn 1 1
Patient Problem/Medical Problem 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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