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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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New Search show TPLC since Back to Search Results
Device humidifier, respiratory gas, (direct patient interface)
Product CodeBTT
Regulation Number 868.5450
Device Class 2


Premarket Reviews
ManufacturerDecision
FISHER & PAYKEL HEALTHCARE
  SUBSTANTIALLY EQUIVALENT 1
FISHER & PAYKEL HEALTHCARE LTD
  SUBSTANTIALLY EQUIVALENT 3
FISHER & PAYKEL HEALTHCARE LTD.
  SUBSTANTIALLY EQUIVALENT 1
FISHER &PAYKEL HEALTHCARE LTD.
  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

MDR Year MDR Reports MDR Events
2018 918 918
2019 894 894
2020 1188 1188
2021 1508 1508
2022 751 751
2023 236 236

Device Problems MDRs with this Device Problem Events in those MDRs
No Audible Alarm 2869 2869
Material Split, Cut or Torn 335 335
Break 329 329
Leak/Splash 323 323
Insufficient Heating 305 305
Crack 294 294
Fluid/Blood Leak 233 233
Failure to Power Up 186 186
Device Alarm System 126 126
Detachment of Device or Device Component 118 118
Complete Loss of Power 82 82
Gas/Air Leak 60 60
Power Problem 58 58
Adverse Event Without Identified Device or Use Problem 53 53
Melted 53 53
Disconnection 51 51
Mechanical Problem 47 47
Defective Alarm 46 46
Overfill 43 43
Temperature Problem 42 42
Therapeutic or Diagnostic Output Failure 32 32
Overheating of Device 30 30
Material Puncture/Hole 27 27
No Audible Prompt/Feedback 27 27
Use of Device Problem 26 26
Defective Component 25 25
Infusion or Flow Problem 23 23
Obstruction of Flow 20 20
Improper Flow or Infusion 19 19
Unexpected Shutdown 18 18
Insufficient Information 18 18
Defective Device 18 18
Device Displays Incorrect Message 18 18
Output Problem 16 16
Improper or Incorrect Procedure or Method 16 16
No Apparent Adverse Event 16 16
Misconnection 15 15
No Flow 15 15
Protective Measures Problem 15 15
Moisture or Humidity Problem 13 13
Difficult to Open or Close 13 13
Loose or Intermittent Connection 13 13
Incorrect, Inadequate or Imprecise Result or Readings 13 13
Connection Problem 12 12
Failure to Deliver 12 12
Loss of Power 11 11
Fire 10 10
Device Sensing Problem 10 10
Unintended Movement 10 10
Device Handling Problem 9 9
Intermittent Loss of Power 9 9
Material Integrity Problem 9 9
Failure of Device to Self-Test 9 9
Noise, Audible 8 8
False Alarm 8 8
Device Emits Odor 8 8
Stretched 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
Failure to Read Input Signal 5 5
Electrical /Electronic Property Problem 5 5
Corroded 4 4
Thermal Decomposition of Device 4 4
Failure to Select Signal 4 4
Device Slipped 4 4
Material Separation 4 4
Device Damaged Prior to Use 4 4
Ambient Temperature Problem 4 4
Excessive Heating 4 4
Device Operates Differently Than Expected 3 3
Human-Device Interface Problem 3 3
Material Twisted/Bent 3 3
Audible Prompt/Feedback Problem 3 3
Physical Resistance/Sticking 3 3
No Device Output 3 3
Incorrect Measurement 3 3
Loss of or Failure to Bond 3 3
Complete Blockage 3 3
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
Appropriate Term/Code Not Available 2 2
Material Protrusion/Extrusion 2 2
Manufacturing, Packaging or Shipping Problem 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 2650 2650
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 193 193
Insufficient Information 81 81
Death 25 25
No Information 14 14
Burn(s) 10 10
Hypoxia 8 8
Bradycardia 8 8
Respiratory Distress 7 7
Obstruction/Occlusion 6 6
Cardiac Arrest 6 6
Partial thickness (Second Degree) Burn 6 6
Airway Obstruction 4 4
Dyspnea 4 4
Viral Infection 4 4
Discomfort 3 3
Pneumonia 3 3
Tachycardia 3 3
Superficial (First Degree) Burn 3 3
Patient Problem/Medical Problem 3 3
No Code Available 2 2
Respiratory Arrest 2 2
Full thickness (Third Degree) Burn 2 2
Increased Respiratory Rate 2 2
Burn, Thermal 2 2
Cough 2 2
Pressure Sores 2 2
Aspiration/Inhalation 2 2
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
Distress 1 1
Complaint, Ill-Defined 1 1
Ventilator Dependent 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
Epistaxis 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Electric Shock 1 1
Blood Loss 1 1
Fibrosis 1 1
Respiratory Insufficiency 1 1
Unspecified Respiratory Problem 1 1
Blister 1 1
Cancer 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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