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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 294 294

Device Problems MDRs with this Device Problem Events in those MDRs
No Audible Alarm 1803 1803
Material Split, Cut or Torn 533 533
Leak/Splash 355 355
Break 355 355
Crack 314 314
Insufficient Heating 300 300
Fluid/Blood Leak 292 292
Detachment of Device or Device Component 267 267
Failure to Power Up 181 181
Gas/Air Leak 104 104
Device Alarm System 103 103
Melted 87 87
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 42 42
Stretched 35 35
Overfill 34 34
Insufficient Information 31 31
Material Puncture/Hole 31 31
Therapeutic or Diagnostic Output Failure 28 28
No Audible Prompt/Feedback 24 24
Overheating of Device 24 24
Device Dislodged or Dislocated 23 23
Infusion or Flow Problem 21 21
Unexpected Shutdown 18 18
Improper Flow or Infusion 17 17
Obstruction of Flow 17 17
Use of Device Problem 17 17
Output Problem 16 16
Connection Problem 15 15
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
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
Loose or Intermittent Connection 10 10
Sparking 10 10
Material Integrity Problem 10 10
Intermittent Loss of Power 9 9
Fire 9 9

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 3789 3789
No Patient Involvement 350 350
No Known Impact Or Consequence To Patient 314 314
Low Oxygen Saturation 251 251
Insufficient Information 106 106
No Consequences Or Impact To Patient 87 87
Burn(s) 14 14
Death 12 12
Hypoxia 12 12
No Information 12 12
Cardiac Arrest 9 9
Bradycardia 8 8
Partial thickness (Second Degree) Burn 8 8
Superficial (First Degree) Burn 6 6
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
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
Tachycardia 3 3
Respiratory Arrest 3 3
Respiratory Failure 3 3
Dyspnea 3 3
Discomfort 3 3
Increased Respiratory Rate 2 2
Pain 2 2
Pressure Sores 2 2
Blister 2 2
Burn, Thermal 2 2
Respiratory Distress 2 2
Full thickness (Third Degree) Burn 2 2
Bacterial Infection 1 1
Inadequate Pain Relief 1 1
Irritability 1 1
Hyperventilation 1 1
Fibrosis 1 1
Respiratory Insufficiency 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
Swelling 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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