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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 1
FISHER & PAYKEL HEALTHCARE LTD
  SUBSTANTIALLY EQUIVALENT 2
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
  1.  K191010  Palladium High Flow Therapy System
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 100 100

Device Problems MDRs with this Device Problem Events in those MDRs
No Audible Alarm 2827 2827
Break 325 325
Material Split, Cut or Torn 314 314
Leak/Splash 311 311
Insufficient Heating 305 305
Crack 276 276
Fluid/Blood Leak 202 202
Failure to Power Up 186 186
Device Alarm System 126 126
Detachment of Device or Device Component 113 113
Complete Loss of Power 82 82
Power Problem 57 57
Gas/Air Leak 54 54
Adverse Event Without Identified Device or Use Problem 53 53
Disconnection 51 51
Melted 51 51
Defective Alarm 44 44
Overfill 42 42
Temperature Problem 41 41
Mechanical Problem 41 41
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 22 22
Improper Flow or Infusion 19 19
Obstruction of Flow 19 19
Defective Device 18 18
Device Displays Incorrect Message 18 18
Insufficient Information 17 17
Unexpected Shutdown 17 17
No Apparent Adverse Event 16 16
Output Problem 16 16
No Flow 15 15
Protective Measures Problem 15 15
Improper or Incorrect Procedure or Method 15 15
Misconnection 15 15
Loose or Intermittent Connection 13 13
Incorrect, Inadequate or Imprecise Result or Readings 13 13
Difficult to Open or Close 13 13
Connection Problem 12 12
Failure to Deliver 12 12
Moisture or Humidity Problem 12 12
Loss of Power 11 11
Fire 10 10
Device Sensing Problem 10 10
Failure of Device to Self-Test 9 9
Material Integrity Problem 9 9
Device Handling Problem 9 9
Unintended Movement 9 9
Intermittent Loss of Power 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
Smoking 6 6
Failure to Sense 6 6
Contamination /Decontamination Problem 6 6
Inaudible or Unclear Audible Prompt/Feedback 6 6
Sparking 6 6
Device Issue 5 5
Material Deformation 5 5
Failure to Read Input Signal 5 5
Electrical /Electronic Property Problem 5 5
Degraded 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
Excessive Heating 4 4
Device Damaged Prior to Use 4 4
Ambient Temperature Problem 4 4
Component Missing 3 3
Device Operates Differently Than Expected 3 3
Human-Device Interface Problem 3 3
Physical Resistance/Sticking 3 3
Material Twisted/Bent 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
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
Material Protrusion/Extrusion 2 2
Manufacturing, Packaging or Shipping Problem 2 2
Device Fell 2 2
Appropriate Term/Code Not Available 2 2
Flare or Flash 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 2522 2522
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 187 187
Insufficient Information 80 80
Death 25 25
No Information 14 14
Hypoxia 8 8
Bradycardia 8 8
Burn(s) 8 8
Respiratory Distress 7 7
Cardiac Arrest 6 6
Partial thickness (Second Degree) Burn 6 6
Obstruction/Occlusion 6 6
Airway Obstruction 4 4
Dyspnea 4 4
Viral Infection 4 4
Discomfort 3 3
Pneumonia 3 3
Tachycardia 3 3
Patient Problem/Medical Problem 3 3
Full thickness (Third Degree) Burn 2 2
No Code Available 2 2
Respiratory Arrest 2 2
Pressure Sores 2 2
Increased Respiratory Rate 2 2
Burn, Thermal 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
Electric Shock 1 1
Blood Loss 1 1
Distress 1 1
Complaint, Ill-Defined 1 1
Ventilator Dependent 1 1
Virus 1 1
Chronic Obstructive Pulmonary Disease (COPD) 1 1
Abrasion 1 1
Skin Erosion 1 1
Swelling 1 1
Respiratory Insufficiency 1 1
Unspecified Respiratory Problem 1 1
Blister 1 1
Cancer 1 1
Cough 1 1
Epistaxis 1 1
Fibrosis 1 1
Respiratory Failure 1 1
Superficial (First Degree) Burn 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 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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