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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
HAMILTON MEDICAL AG
  SUBSTANTIALLY EQUIVALENT 1
PERMA PURE LLC
  SUBSTANTIALLY EQUIVALENT 1
SALTER LABS
  SUBSTANTIALLY EQUIVALENT 1
TELEFLEX MEDICAL, INC
  SUBSTANTIALLY EQUIVALENT 1
TNI MEDICAL AG
  SUBSTANTIALLY EQUIVALENT 1
VAPOTHERM INC.
  SUBSTANTIALLY EQUIVALENT 1
VAPOTHERM, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 1007 1007
2018 918 918
2019 894 894
2020 1188 1188
2021 1508 1508
2022 621 621

Device Problems MDRs with this Device Problem Events in those MDRs
No Audible Alarm 3513 3513
Leak/Splash 347 347
Break 316 316
Crack 314 314
Insufficient Heating 310 310
Material Split, Cut or Torn 268 268
Fluid/Blood Leak 201 201
Failure to Power Up 187 187
Device Alarm System 132 132
Detachment of Device or Device Component 98 98
Complete Loss of Power 82 82
Temperature Problem 60 60
Power Problem 59 59
Adverse Event Without Identified Device or Use Problem 54 54
Gas/Air Leak 50 50
Disconnection 49 49
Melted 49 49
Overheating of Device 42 42
Overfill 42 42
Device Operates Differently Than Expected 38 38
Mechanical Problem 37 37
Therapeutic or Diagnostic Output Failure 32 32
Use of Device Problem 29 29
Defective Alarm 29 29
No Audible Prompt/Feedback 27 27
Material Puncture/Hole 27 27
Defective Component 25 25
Device Displays Incorrect Message 23 23
Infusion or Flow Problem 21 21
Improper Flow or Infusion 19 19
Connection Problem 19 19
Defective Device 18 18
Device Issue 18 18
Device Handling Problem 18 18
Unexpected Shutdown 17 17
Failure to Deliver 17 17
Obstruction of Flow 17 17
No Flow 16 16
No Apparent Adverse Event 16 16
Output Problem 16 16
Misconnection 16 16
Improper or Incorrect Procedure or Method 16 16
Difficult to Open or Close 15 15
Protective Measures Problem 14 14
Loss of Power 14 14
Loose or Intermittent Connection 14 14
Incorrect, Inadequate or Imprecise Result or Readings 13 13
Insufficient Information 13 13
Moisture or Humidity Problem 13 13
False Alarm 11 11
Hole In Material 10 10
Device Sensing Problem 10 10
Failure of Device to Self-Test 9 9
Intermittent Loss of Power 9 9
Noise, Audible 9 9
Filling Problem 9 9
Fire 9 9
Device Emits Odor 9 9
Smoking 8 8
Display or Visual Feedback Problem 7 7
Material Integrity Problem 7 7
Material Deformation 6 6
Unintended Movement 6 6
Contamination /Decontamination Problem 6 6
Electrical /Electronic Property Problem 6 6
Thermal Decomposition of Device 6 6
Failure to Sense 6 6
Inaudible or Unclear Audible Prompt/Feedback 6 6
Stretched 5 5
Failure to Read Input Signal 5 5
Degraded 5 5
Material Discolored 4 4
Corroded 4 4
Failure to Select Signal 4 4
Device Slipped 4 4
Material Separation 4 4
Device Damaged Prior to Use 4 4
Sparking 4 4
Ambient Temperature Problem 4 4
Inaccurate Delivery 3 3
Component Missing 3 3
Human-Device Interface Problem 3 3
Appropriate Term/Code Not Available 3 3
Physical Resistance/Sticking 3 3
Audible Prompt/Feedback Problem 3 3
Material Twisted/Bent 3 3
Manufacturing, Packaging or Shipping Problem 3 3
Device Stops Intermittently 3 3
No Device Output 3 3
Air Leak 3 3
Burst Container or Vessel 3 3
Complete Blockage 3 3
Low Audible Alarm 3 3
Incorrect Measurement 3 3
No Display/Image 3 3
Excessive Heating 3 3
Gas Output Problem 2 2
Unintended Ejection 2 2
Moisture Damage 2 2
Failure to Reset 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 2319 2319
No Patient Involvement 1920 1920
No Known Impact Or Consequence To Patient 1076 1076
No Consequences Or Impact To Patient 516 516
Low Oxygen Saturation 178 178
Insufficient Information 76 76
Death 25 25
No Information 17 17
Burn(s) 10 10
Hypoxia 8 8
Bradycardia 8 8
Respiratory Distress 8 8
Partial thickness (Second Degree) Burn 7 7
Obstruction/Occlusion 6 6
Discomfort 5 5
Cardiac Arrest 5 5
Airway Obstruction 4 4
Dyspnea 4 4
Viral Infection 4 4
No Code Available 4 4
Patient Problem/Medical Problem 3 3
Tachycardia 3 3
Pressure Sores 2 2
Pneumonia 2 2
Ventilator Dependent 2 2
Unspecified Infection 2 2
Aspiration/Inhalation 2 2
Superficial (First Degree) Burn 2 2
Increased Respiratory Rate 2 2
Burn, Thermal 2 2
Respiratory Arrest 2 2
Respiratory Insufficiency 1 1
Unspecified Respiratory Problem 1 1
Blister 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Confusion/ Disorientation 1 1
Electric Shock 1 1
Blood Loss 1 1
Cancer 1 1
Epistaxis 1 1
Full thickness (Third Degree) Burn 1 1
Fibrosis 1 1
Asthma 1 1
Bacterial Infection 1 1
Arrhythmia 1 1
Stroke/CVA 1 1
Cyanosis 1 1
Inflammation 1 1
Myocardial Infarction 1 1
Neurological Deficit/Dysfunction 1 1
Pain 1 1
Erythema 1 1
Fever 1 1
Low Blood Pressure/ Hypotension 1 1
Hypothermia 1 1
Respiratory Failure 1 1
Distress 1 1
Complaint, Ill-Defined 1 1
Virus 1 1
Chronic Obstructive Pulmonary Disease (COPD) 1 1
Skin Erosion 1 1
Swelling 1 1
Abrasion 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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