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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
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

Device Problems MDRs with this Device Problem Events in those MDRs
No Audible Alarm 2786 2786
Break 322 322
Leak/Splash 307 307
Insufficient Heating 304 304
Material Split, Cut or Torn 290 290
Crack 272 272
Fluid/Blood Leak 197 197
Failure to Power Up 186 186
Device Alarm System 126 126
Detachment of Device or Device Component 104 104
Complete Loss of Power 82 82
Power Problem 57 57
Gas/Air Leak 54 54
Adverse Event Without Identified Device or Use Problem 52 52
Disconnection 50 50
Melted 49 49
Overfill 42 42
Temperature Problem 40 40
Defective Alarm 40 40
Mechanical Problem 38 38
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 21 21
Improper Flow or Infusion 19 19
Obstruction of Flow 18 18
Defective Device 18 18
Device Displays Incorrect Message 18 18
Unexpected Shutdown 17 17
No Apparent Adverse Event 16 16
Insufficient Information 16 16
Output Problem 16 16
No Flow 15 15
Improper or Incorrect Procedure or Method 15 15
Misconnection 15 15
Protective Measures Problem 14 14
Difficult to Open or Close 13 13
Incorrect, Inadequate or Imprecise Result or Readings 13 13
Loose or Intermittent Connection 13 13
Connection Problem 12 12
Moisture or Humidity Problem 12 12
Failure to Deliver 12 12
Loss of Power 11 11
Fire 10 10
Device Sensing Problem 10 10
Material Integrity Problem 9 9
Failure of Device to Self-Test 9 9
Device Handling Problem 9 9
Intermittent Loss of Power 9 9
Device Emits Odor 8 8
Unintended Movement 8 8
False Alarm 8 8
Stretched 8 8
Noise, Audible 8 8
Display or Visual Feedback Problem 7 7
Filling Problem 7 7
Contamination /Decontamination Problem 6 6
Inaudible or Unclear Audible Prompt/Feedback 6 6
Failure to Sense 6 6
Device Issue 5 5
Sparking 5 5
Failure to Read Input Signal 5 5
Material Deformation 5 5
Electrical /Electronic Property Problem 5 5
Degraded 5 5
Smoking 5 5
Device Slipped 4 4
Device Damaged Prior to Use 4 4
Thermal Decomposition of Device 4 4
Failure to Select Signal 4 4
Excessive Heating 4 4
Corroded 4 4
Ambient Temperature Problem 4 4
Material Separation 4 4
Complete Blockage 3 3
Device Operates Differently Than Expected 3 3
Human-Device Interface Problem 3 3
Material Twisted/Bent 3 3
Physical Resistance/Sticking 3 3
Audible Prompt/Feedback Problem 3 3
No Device Output 3 3
Component Missing 3 3
Loss of or Failure to Bond 3 3
Incorrect Measurement 3 3
Low Audible Alarm 2 2
Unintended Ejection 2 2
Inaccurate Delivery 2 2
Cut In Material 2 2
Device Dislodged or Dislocated 2 2
Appropriate Term/Code Not Available 2 2
Manufacturing, Packaging or Shipping Problem 2 2
Short Fill 2 2
Failure to Reset 2 2
Device Fell 2 2
Tear, Rip or Hole in Device Packaging 2 2
Device Stops Intermittently 2 2
Material Protrusion/Extrusion 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 2432 2432
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 178 178
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
Dyspnea 4 4
Viral Infection 4 4
Airway Obstruction 4 4
Tachycardia 3 3
Patient Problem/Medical Problem 3 3
Increased Respiratory Rate 2 2
No Code Available 2 2
Respiratory Arrest 2 2
Aspiration/Inhalation 2 2
Discomfort 2 2
Pneumonia 2 2
Full thickness (Third Degree) Burn 2 2
Burn, Thermal 2 2
Pressure Sores 2 2
Superficial (First Degree) Burn 1 1
Erythema 1 1
Fever 1 1
Hypothermia 1 1
Cancer 1 1
Cough 1 1
Unspecified Respiratory Problem 1 1
Blood Loss 1 1
Fibrosis 1 1
Blister 1 1
Asthma 1 1
Unspecified Infection 1 1
Pain 1 1
Complaint, Ill-Defined 1 1
Ventilator Dependent 1 1
Distress 1 1
Abrasion 1 1
Cyanosis 1 1
Low Blood Pressure/ Hypotension 1 1
Inflammation 1 1
Neurological Deficit/Dysfunction 1 1
Skin Erosion 1 1
Swelling 1 1
Respiratory Failure 1 1
Epistaxis 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Respiratory Insufficiency 1 1
Electric Shock 1 1
Stroke/CVA 1 1
Arrhythmia 1 1
Bacterial Infection 1 1
Myocardial Infarction 1 1
Virus 1 1
Chronic Obstructive Pulmonary Disease (COPD) 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 Vyaire Medical I Jan-24-2018
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