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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 2
FISHER & PAYKEL HEALTHCARE LTD
  SUBSTANTIALLY EQUIVALENT 8
FISHER & PAYKEL HEALTHCARE LTD.
  SUBSTANTIALLY EQUIVALENT 1
FISHER &PAYKEL HEALTHCARE LTD.
  SUBSTANTIALLY EQUIVALENT 1
HOMETA INC
  SUBSTANTIALLY EQUIVALENT 1
INVENT MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
LABORATORIOS BIOGALENIC, S.A. DE C.V.
  SUBSTANTIALLY EQUIVALENT 1
MEDLINE INDUSTRIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDLINE INDUSTRIES, LP.
  SUBSTANTIALLY EQUIVALENT 3
PERMA PURE LLC
  SUBSTANTIALLY EQUIVALENT 1
TELESAIR, 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
2020 1188 1188
2021 1508 1508
2022 749 749
2023 717 717
2024 501 501
2025 355 355

Device Problems MDRs with this Device Problem Events in those MDRs
No Audible Alarm 1815 1815
Material Split, Cut or Torn 544 544
Leak/Splash 364 364
Break 357 357
Crack 336 336
Insufficient Heating 300 300
Fluid/Blood Leak 295 295
Detachment of Device or Device Component 283 283
Failure to Power Up 181 181
Gas/Air Leak 107 107
Device Alarm System 103 103
Melted 89 89
Complete Loss of Power 83 83
Defective Alarm 81 81
Mechanical Problem 79 79
Power Problem 57 57
Disconnection 51 51
Temperature Problem 48 48
Adverse Event Without Identified Device or Use Problem 43 43
Stretched 43 43
Material Puncture/Hole 35 35
Overfill 34 34
Insufficient Information 31 31
Therapeutic or Diagnostic Output Failure 28 28
No Audible Prompt/Feedback 24 24
Overheating of Device 24 24
Infusion or Flow Problem 21 21
Device Dislodged or Dislocated 21 21
Unexpected Shutdown 18 18
Use of Device Problem 18 18
Improper Flow or Infusion 17 17
Obstruction of Flow 17 17
Output Problem 16 16
Connection Problem 16 16
Misconnection 14 14
Moisture or Humidity Problem 14 14
Protective Measures Problem 14 14
Defective Device 13 13
Contamination /Decontamination Problem 12 12
Failure to Read Input Signal 11 11
Loose or Intermittent Connection 11 11
Unintended Movement 11 11
Difficult to Open or Close 11 11
Improper or Incorrect Procedure or Method 11 11
No Flow 11 11
Device Emits Odor 10 10
Sparking 10 10
Material Integrity Problem 10 10
Corroded 9 9
Intermittent Loss of Power 9 9

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 3842 3842
No Patient Involvement 350 350
No Known Impact Or Consequence To Patient 314 314
Low Oxygen Saturation 257 257
Insufficient Information 107 107
No Consequences Or Impact To Patient 87 87
Burn(s) 14 14
Hypoxia 13 13
Death 12 12
No Information 12 12
Cardiac Arrest 9 9
Bradycardia 8 8
Partial thickness (Second Degree) Burn 8 8
Superficial (First Degree) Burn 7 7
Unspecified Respiratory Problem 6 6
Obstruction/Occlusion 5 5
Cancer 5 5
Cough 4 4
Pneumonia 4 4
Airway Obstruction 4 4
Viral Infection 4 4
Tachycardia 3 3
Dyspnea 3 3
Discomfort 3 3
Respiratory Arrest 3 3
Respiratory Failure 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
Blister 2 2
Pressure Sores 2 2
Burn, Thermal 2 2
Respiratory Distress 2 2
Pain 2 2
Full thickness (Third Degree) Burn 2 2
Increased Respiratory Rate 2 2
Respiratory Insufficiency 1 1
Bacterial Infection 1 1
Fibrosis 1 1
Inadequate Pain Relief 1 1
Irritability 1 1
Hyperventilation 1 1
Low Blood Pressure/ Hypotension 1 1
Ventilator Dependent 1 1
Decreased Respiratory Rate 1 1
Distress 1 1
Heart Failure/Congestive Heart Failure 1 1
Nasal Obstruction 1 1
Unspecified Kidney or Urinary Problem 1 1
Hypothermia 1 1
Respiratory Tract Infection 1 1
Erythema 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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