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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)
Regulation Description Respiratory gas humidifier.
Product CodeBTT
Regulation Number 868.5450
Device Class 2


Premarket Reviews
ManufacturerDecision
FISHER & PAYKEL HEALTHCARE
  SUBSTANTIALLY EQUIVALENT 3
FISHER & PAYKEL HEALTHCARE, LTD.
  SUBSTANTIALLY EQUIVALENT 11
FISHER AND PAYKEL HEALTHCARE LIMITED
  SUBSTANTIALLY EQUIVALENT 1
FLEXICARE MEDICAL LIMITED.
  SUBSTANTIALLY EQUIVALENT 1
HOMETA, INC.
  SUBSTANTIALLY EQUIVALENT 1
INVENT MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
LABORATORIOS BIOGALENIC S.A. DE C.V.
  SUBSTANTIALLY EQUIVALENT 2
MEDLINE INDUSTRIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDLINE INDUSTRIES, LP
  SUBSTANTIALLY EQUIVALENT 3
PERMA PURE, LLC
  SUBSTANTIALLY EQUIVALENT 1
TELESAIR, INC.
  SUBSTANTIALLY EQUIVALENT 1
TNI MEDICAL AG
  SUBSTANTIALLY EQUIVALENT 1
VAPOTHERM, INC.
  SUBSTANTIALLY EQUIVALENT 3
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 1198
2021 1510 1511
2022 749 749
2023 716 736
2024 500 505
2025 1755 1759
2026 2524 2525

Device Problems MDRs with this Device Problem Events in those MDRs
No Audible Alarm 3334 3334
Defective Alarm 2875 2878
Material Split, Cut or Torn 661 666
Detachment of Device or Device Component 507 518
Crack 417 421
Leak/Splash 397 400
Insufficient Heating 339 339
Fluid/Blood Leak 329 330
Failure to Power Up 228 228
Break 172 182
Gas/Air Leak 163 163
Mechanical Problem 99 100
Device Alarm System 90 90
Complete Loss of Power 83 83
Melted 79 79
Power Problem 73 73
Unexpected Shutdown 61 61
Stretched 57 58
Insufficient Device Problem Information 52 52
Adverse Event Without Identified Device or Use Problem 52 52
Temperature Problem 49 49
Overfill 38 38
Device Dislodged or Dislocated 36 36
Disconnection 31 31
Use of Device Problem 29 29
Overheating of Device 28 28
Material Puncture/Hole 26 26
Obstruction of Flow 26 26
Infusion or Flow Problem 24 24
Excessive Heating 22 22
No Apparent Adverse Event 22 22
Material Integrity Problem 21 21
Misconnection 19 19
Improper Flow or Infusion 18 18
Moisture or Humidity Problem 17 17
Loose or Intermittent Connection 16 16
Connection Problem 15 16
Fire 15 15
Display or Visual Feedback Problem 15 15
Difficult to Open or Close 14 14
Unintended Movement 14 14
Appropriate Device Problem Term/Code Not Available 13 13
Contamination /Decontamination Problem 13 13
Material Deformation 12 13
Fitting Problem 12 12
Electrical /Electronic Property Problem 11 11
No Flow 11 11
Intermittent Loss of Power 11 11
Failure to Read Input Signal 11 11
Device Sensing Problem 10 10

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 7676 7711
No Patient Involvement 1279 1279
No Known Impact Or Consequence To Patient 920 922
Low Oxygen Saturation 347 349
No Consequences Or Impact To Patient 319 320
Insufficient Information 128 129
Death 25 25
Hypoxia 19 19
Burn(s) 18 18
No Information 14 14
Bradycardia 13 13
Partial thickness (Second Degree) Burn 12 12
Superficial (First Degree) Burn 10 10
Cardiac Arrest 10 10
Airway Obstruction 9 9
Unspecified Respiratory Problem 7 7
Respiratory Distress 7 7
Cough 6 6
Obstruction/Occlusion 6 6
Dyspnea 5 5
Aspiration/Inhalation 5 5
Tachycardia 4 4
Pneumonia 4 4
Discomfort 4 4
Viral Infection 4 4
Cancer 4 4
Blister 3 3
Respiratory Failure 3 3
Full thickness (Third Degree) Burn 3 3
Respiratory Arrest 3 3
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available 3 3
Patient Problem/Medical Problem 3 3
Eye Irritation 2 2
Burn, Thermal 2 3
Asthma 2 2
Skin Inflammation/ Irritation 2 2
No Code Available 2 2
Hypothermia 2 2
Pain 2 2
Pressure Sore/Ulcer 2 2
Distress 2 2
Increased Respiratory Rate 2 2
Respiratory Insufficiency 1 1
Fibrosis 1 1
Irritability 1 1
Inadequate Pain Relief 1 1
Headache 1 1
Bacterial Infection 1 1
Myocardial Infarction 1 1
Hyperventilation 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Fisher & Paykel Healthcare, Ltd. II Oct-15-2025
2 Fisher & Paykel Healthcare, Ltd. II May-15-2024
3 Hamilton Medical AG III Jul-14-2022
4 Medline Industries, LP II Aug-21-2026
5 TELEFLEX MEDICAL INC I Feb-07-2020
6 Vapotherm II Mar-17-2023
7 Vyaire Medical I Jan-24-2018
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