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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device humidifier, respiratory gas, (direct patient interface)
Product CodeBTT
Regulation Number 868.5450
Device Class 2


Premarket Reviews
ManufacturerDecision
FISHER & PAYKEL HEALTHCARE
  SUBSTANTIALLY EQUIVALENT 2
FISHER & PAYKEL HEALTHCARE LTD
  SUBSTANTIALLY EQUIVALENT 4
FISHER & PAYKEL HEALTHCARE LTD.
  SUBSTANTIALLY EQUIVALENT 1
FISHER &PAYKEL HEALTHCARE LTD.
  SUBSTANTIALLY EQUIVALENT 1
HOMETA INC
  SUBSTANTIALLY EQUIVALENT 1
PERMA PURE LLC
  SUBSTANTIALLY EQUIVALENT 1
TNI MEDICAL AG
  SUBSTANTIALLY EQUIVALENT 1
VAPOTHERM INC.
  SUBSTANTIALLY EQUIVALENT 1
VAPOTHERM, INC.
  SUBSTANTIALLY EQUIVALENT 1
VINCENT HEALTHCARE PRODUCTS LIMITED
  SUBSTANTIALLY EQUIVALENT 1
VYAIRE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2018 918 918
2019 894 894
2020 1188 1188
2021 1508 1508
2022 749 749
2023 494 494

Device Problems MDRs with this Device Problem Events in those MDRs
No Audible Alarm 2962 2962
Material Split, Cut or Torn 365 365
Leak/Splash 343 343
Break 328 328
Crack 326 326
Insufficient Heating 306 306
Fluid/Blood Leak 272 272
Failure to Power Up 186 186
Device Alarm System 129 129
Detachment of Device or Device Component 125 125
Complete Loss of Power 83 83
Melted 64 64
Gas/Air Leak 63 63
Power Problem 58 58
Adverse Event Without Identified Device or Use Problem 56 56
Defective Alarm 55 55
Mechanical Problem 52 52
Disconnection 51 51
Overfill 46 46
Temperature Problem 45 45
Therapeutic or Diagnostic Output Failure 32 32
Overheating of Device 30 30
Material Puncture/Hole 28 28
Use of Device Problem 27 27
No Audible Prompt/Feedback 27 27
Defective Component 25 25
Infusion or Flow Problem 24 24
Insufficient Information 20 20
Obstruction of Flow 20 20
Improper Flow or Infusion 19 19
Defective Device 18 18
Device Displays Incorrect Message 18 18
Unexpected Shutdown 18 18
Improper or Incorrect Procedure or Method 17 17
Misconnection 16 16
Output Problem 16 16
No Apparent Adverse Event 16 16
No Flow 15 15
Protective Measures Problem 15 15
Moisture or Humidity Problem 14 14
Difficult to Open or Close 14 14
Loose or Intermittent Connection 13 13
Incorrect, Inadequate or Imprecise Result or Readings 13 13
Loss of Power 12 12
Connection Problem 12 12
Failure to Deliver 12 12
Device Emits Odor 11 11
Failure to Read Input Signal 11 11
Stretched 11 11
Fire 11 11
Device Sensing Problem 10 10
Unintended Movement 10 10
Intermittent Loss of Power 9 9
Device Handling Problem 9 9
Material Integrity Problem 9 9
Failure of Device to Self-Test 9 9
Noise, Audible 8 8
False Alarm 8 8
Filling Problem 7 7
Display or Visual Feedback Problem 7 7
Degraded 6 6
Smoking 6 6
Failure to Sense 6 6
Contamination /Decontamination Problem 6 6
Inaudible or Unclear Audible Prompt/Feedback 6 6
Sparking 6 6
Component Missing 5 5
Device Issue 5 5
Material Deformation 5 5
Electrical /Electronic Property Problem 5 5
Corroded 5 5
Thermal Decomposition of Device 5 5
Excessive Heating 5 5
Material Separation 4 4
Failure to Select Signal 4 4
Device Slipped 4 4
Device Damaged Prior to Use 4 4
Ambient Temperature Problem 4 4
Device Operates Differently Than Expected 3 3
Human-Device Interface Problem 3 3
Material Twisted/Bent 3 3
Physical Resistance/Sticking 3 3
Appropriate Term/Code Not Available 3 3
No Device Output 3 3
Incorrect Measurement 3 3
Loss of or Failure to Bond 3 3
Complete Blockage 3 3
Audible Prompt/Feedback Problem 3 3
Incomplete or Inadequate Connection 2 2
Air Leak 2 2
Burst Container or Vessel 2 2
Low Audible Alarm 2 2
No Display/Image 2 2
Unintended Ejection 2 2
Hole In Material 2 2
Failure to Reset 2 2
Device Stops Intermittently 2 2
Fitting Problem 2 2
Device Fell 2 2
Patient Device Interaction Problem 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 2882 2882
No Patient Involvement 1279 1279
No Known Impact Or Consequence To Patient 920 920
No Consequences Or Impact To Patient 319 319
Low Oxygen Saturation 203 203
Insufficient Information 85 85
Death 25 25
Burn(s) 14 14
No Information 14 14
Bradycardia 9 9
Hypoxia 8 8
Cardiac Arrest 7 7
Respiratory Distress 7 7
Partial thickness (Second Degree) Burn 7 7
Obstruction/Occlusion 6 6
Viral Infection 4 4
Airway Obstruction 4 4
Dyspnea 4 4
Superficial (First Degree) Burn 4 4
Cough 4 4
Respiratory Arrest 3 3
Patient Problem/Medical Problem 3 3
Pneumonia 3 3
Aspiration/Inhalation 3 3
Discomfort 3 3
Tachycardia 3 3
Pressure Sores 2 2
Unspecified Respiratory Problem 2 2
No Code Available 2 2
Full thickness (Third Degree) Burn 2 2
Increased Respiratory Rate 2 2
Burn, Thermal 2 2
Electric Shock 1 1
Blood Loss 1 1
Fibrosis 1 1
Cancer 1 1
Respiratory Insufficiency 1 1
Epistaxis 1 1
Blister 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Distress 1 1
Complaint, Ill-Defined 1 1
Ventilator Dependent 1 1
Nasal Obstruction 1 1
Respiratory Failure 1 1
Virus 1 1
Chronic Obstructive Pulmonary Disease (COPD) 1 1
Skin Erosion 1 1
Swelling 1 1
Abrasion 1 1
Asthma 1 1
Bacterial Infection 1 1
Arrhythmia 1 1
Stroke/CVA 1 1
Cyanosis 1 1
Erythema 1 1
Fever 1 1
Low Blood Pressure/ Hypotension 1 1
Hypothermia 1 1
Unspecified Infection 1 1
Inflammation 1 1
Myocardial Infarction 1 1
Neurological Deficit/Dysfunction 1 1
Pain 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Hamilton Medical AG III Jul-14-2022
2 TELEFLEX MEDICAL INC I Feb-07-2020
3 Vapotherm II Mar-17-2023
4 Vyaire Medical I Jan-24-2018
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