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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 5
FISHER & PAYKEL HEALTHCARE LTD.
  SUBSTANTIALLY EQUIVALENT 1
FISHER &PAYKEL HEALTHCARE LTD.
  SUBSTANTIALLY EQUIVALENT 1
HOMETA INC
  SUBSTANTIALLY EQUIVALENT 1
MEDLINE INDUSTRIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
PERMA PURE LLC
  SUBSTANTIALLY EQUIVALENT 1
TELESAIR, INC.
  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
2019 894 894
2020 1188 1188
2021 1508 1508
2022 749 749
2023 704 704
2024 156 156

Device Problems MDRs with this Device Problem Events in those MDRs
No Audible Alarm 2347 2347
Material Split, Cut or Torn 434 434
Leak/Splash 335 335
Break 328 328
Crack 318 318
Insufficient Heating 304 304
Fluid/Blood Leak 291 291
Failure to Power Up 184 184
Detachment of Device or Device Component 146 146
Device Alarm System 129 129
Complete Loss of Power 83 83
Defective Alarm 75 75
Melted 75 75
Gas/Air Leak 74 74
Mechanical Problem 60 60
Power Problem 57 57
Disconnection 52 52
Adverse Event Without Identified Device or Use Problem 49 49
Temperature Problem 48 48
Overfill 43 43
Therapeutic or Diagnostic Output Failure 32 32
Overheating of Device 28 28
Material Puncture/Hole 28 28
No Audible Prompt/Feedback 26 26
Use of Device Problem 25 25
Infusion or Flow Problem 24 24
Defective Component 23 23
Obstruction of Flow 22 22
Insufficient Information 22 22
Unexpected Shutdown 19 19
Stretched 19 19
Improper Flow or Infusion 18 18
Output Problem 16 16
Improper or Incorrect Procedure or Method 16 16
Misconnection 15 15
Protective Measures Problem 15 15
Defective Device 14 14
Difficult to Open or Close 14 14
Connection Problem 13 13
Device Displays Incorrect Message 13 13
No Flow 13 13
Incorrect, Inadequate or Imprecise Result or Readings 13 13
Loose or Intermittent Connection 13 13
Unintended Movement 12 12
Moisture or Humidity Problem 12 12
Contamination /Decontamination Problem 12 12
Device Emits Odor 11 11
Failure to Read Input Signal 11 11
Loss of Power 10 10
No Apparent Adverse Event 10 10
Intermittent Loss of Power 9 9
Failure of Device to Self-Test 9 9
Material Integrity Problem 9 9
Failure to Deliver 9 9
Fire 9 9
Corroded 8 8
Sparking 8 8
Device Sensing Problem 7 7
Display or Visual Feedback Problem 7 7
Filling Problem 6 6
Smoking 6 6
Failure to Sense 6 6
Excessive Heating 6 6
Noise, Audible 6 6
Material Deformation 5 5
Component Missing 5 5
Inaudible or Unclear Audible Prompt/Feedback 5 5
Failure to Select Signal 5 5
Fitting Problem 5 5
Electrical /Electronic Property Problem 5 5
Degraded 5 5
Thermal Decomposition of Device 5 5
Device Damaged Prior to Use 4 4
Ambient Temperature Problem 4 4
Material Twisted/Bent 3 3
Device Handling Problem 3 3
Physical Resistance/Sticking 3 3
Audible Prompt/Feedback Problem 3 3
Device Slipped 3 3
Material Separation 3 3
Complete Blockage 3 3
False Alarm 3 3
Loss of or Failure to Bond 3 3
Incorrect Measurement 3 3
Inaccurate Flow Rate 2 2
No Display/Image 2 2
Partial Blockage 2 2
Low Audible Alarm 2 2
Burst Container or Vessel 2 2
Product Quality Problem 2 2
Inappropriate Audible Prompt/Feedback 2 2
Tear, Rip or Hole in Device Packaging 2 2
Device Fell 2 2
Incomplete or Inadequate Connection 2 2
Patient Device Interaction Problem 2 2
Material Too Soft/Flexible 2 2
Scratched Material 2 2
Appropriate Term/Code Not Available 2 2
Material Protrusion/Extrusion 2 2
Flare or Flash 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 3208 3208
No Patient Involvement 801 801
No Known Impact Or Consequence To Patient 657 657
Low Oxygen Saturation 211 211
No Consequences Or Impact To Patient 176 176
Insufficient Information 90 90
Death 19 19
Burn(s) 13 13
No Information 12 12
Cardiac Arrest 9 9
Hypoxia 9 9
Bradycardia 9 9
Respiratory Distress 5 5
Obstruction/Occlusion 5 5
Superficial (First Degree) Burn 5 5
Partial thickness (Second Degree) Burn 5 5
Cough 4 4
Unspecified Respiratory Problem 4 4
Viral Infection 4 4
Pneumonia 4 4
Tachycardia 4 4
Dyspnea 4 4
Airway Obstruction 4 4
Aspiration/Inhalation 3 3
Discomfort 3 3
Cancer 3 3
Respiratory Arrest 3 3
Patient Problem/Medical Problem 3 3
Full thickness (Third Degree) Burn 3 3
Increased Respiratory Rate 2 2
Burn, Thermal 2 2
No Code Available 2 2
Pressure Sores 2 2
Nasal Obstruction 1 1
Complaint, Ill-Defined 1 1
Inadequate Pain Relief 1 1
Ventilator Dependent 1 1
Virus 1 1
Burning Sensation 1 1
Chronic Obstructive Pulmonary Disease (COPD) 1 1
Swelling 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
Hyperventilation 1 1
Low Blood Pressure/ Hypotension 1 1
Hypothermia 1 1
Unspecified Infection 1 1
Inflammation 1 1
Neurological Deficit/Dysfunction 1 1
Pain 1 1
Respiratory Insufficiency 1 1
Epistaxis 1 1
Respiratory Failure 1 1
Decreased Respiratory Rate 1 1
Fibrosis 1 1
Blister 1 1
Skin Inflammation/ Irritation 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Fisher & Paykel Healthcare, Ltd. II May-15-2024
2 Hamilton Medical AG III Jul-14-2022
3 TELEFLEX MEDICAL INC I Feb-07-2020
4 Vapotherm II Mar-17-2023
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