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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
CARDINAL HEALTH, INC.
  SUBSTANTIALLY EQUIVALENT 1
CAREFUSION 2200, INC.
  SUBSTANTIALLY EQUIVALENT 1
DRAEGER MEDICAL AG & CO. KG
  SUBSTANTIALLY EQUIVALENT 1
FISHER & PAYKEL HEALTHCARE
  SUBSTANTIALLY EQUIVALENT 3
FISHER & PAYKEL HEALTHCARE LTD
  SUBSTANTIALLY EQUIVALENT 6
FISHER & PAYKEL HEALTHCARE LTD.
  SUBSTANTIALLY EQUIVALENT 1
FISHER & PAYKEL HEALTHCARE, LTD.
  SUBSTANTIALLY EQUIVALENT 7
FISHER &PAYKEL HEALTHCARE LTD.
  SUBSTANTIALLY EQUIVALENT 1
FLEXICARE MEDICAL LIMITED
  SUBSTANTIALLY EQUIVALENT 1
GRUENDLER GMBH
  SUBSTANTIALLY EQUIVALENT 1
GRUNDLER GMBH
  SUBSTANTIALLY EQUIVALENT 1
HAMILTON MEDICAL AG
  SUBSTANTIALLY EQUIVALENT 2
HOMETA INC
  SUBSTANTIALLY EQUIVALENT 1
MEDISIZE BV
  SUBSTANTIALLY EQUIVALENT 1
MEDLINE INDUSTRIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
PACIFIC MEDICO CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
PERMA PURE LLC
  SUBSTANTIALLY EQUIVALENT 1
SALTER LABS
  SUBSTANTIALLY EQUIVALENT 1
  1.  K113542  SALTER LABS BUBBLE HUMIDIFIER (HIGH FLOW)
SALTER LABS, ARVIN FACILITY
  SUBSTANTIALLY EQUIVALENT 1
  1.  K113542  SALTER LABS BUBBLE HUMIDIFIER (HIGH FLOW)
SMITHS MEDICAL ASD, INC.
  SUBSTANTIALLY EQUIVALENT 1
SOMNETICS INTERNATIONAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
TELEFLEX MEDICAL , INC.
  SUBSTANTIALLY EQUIVALENT 1
TELEFLEX MEDICAL, INC
  SUBSTANTIALLY EQUIVALENT 1
TELEFLEX, INC.
  SUBSTANTIALLY EQUIVALENT 3
TELESAIR, INC.
  SUBSTANTIALLY EQUIVALENT 1
TNI MEDICAL AG
  SUBSTANTIALLY EQUIVALENT 1
VAPOTHERM INC.
  SUBSTANTIALLY EQUIVALENT 1
VAPOTHERM, INC.
  SUBSTANTIALLY EQUIVALENT 3
VENTLAB CORP.
  SUBSTANTIALLY EQUIVALENT 1
VINCENT HEALTHCARE PRODUCTS LIMITED
  SUBSTANTIALLY EQUIVALENT 1
VYAIRE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 716 716
2015 669 669
2016 1094 1094
2017 1007 1007
2018 918 918
2019 894 894
2020 1188 1188
2021 1508 1508
2022 749 749
2023 704 704
2024 199 199

Device Problems MDRs with this Device Problem Events in those MDRs
No Audible Alarm 4364 4364
Leak/Splash 625 625
Crack 531 531
Break 455 455
Material Split, Cut or Torn 438 438
Fluid/Blood Leak 418 418
Insufficient Heating 399 399
Failure to Power Up 376 376
Power Problem 287 287
Device Alarm System 247 247
Device Operates Differently Than Expected 217 217
Connection Problem 205 205
Temperature Problem 187 187
Detachment of Device or Device Component 157 157
Melted 111 111
Overheating of Device 93 93
Defective Alarm 92 92
Complete Loss of Power 83 83
Disconnection 78 78
Gas/Air Leak 76 76
Adverse Event Without Identified Device or Use Problem 72 72
Mechanical Problem 63 63
Device Displays Incorrect Message 57 57
Overfill 54 54
Device Issue 46 46
Insufficient Information 37 37
Moisture or Humidity Problem 35 35
No Flow 35 35
Therapeutic or Diagnostic Output Failure 33 33
Use of Device Problem 33 33
Hole In Material 32 32
Failure of Device to Self-Test 31 31
Device Handling Problem 29 29
Material Puncture/Hole 29 29
Defective Component 28 28
Device Sensing Problem 28 28
Infusion or Flow Problem 28 28
No Audible Prompt/Feedback 27 27
Obstruction of Flow 26 26
Protective Measures Problem 26 26
Improper or Incorrect Procedure or Method 25 25
Device Stops Intermittently 24 24
Improper Flow or Infusion 24 24
Air Leak 23 23
No Display/Image 22 22
Fitting Problem 22 22
Stretched 20 20
Loss of Power 20 20
Defective Device 20 20
Detachment Of Device Component 20 20
Misconnection 19 19
Loose or Intermittent Connection 19 19
Device Emits Odor 19 19
Failure to Deliver 19 19
Unexpected Shutdown 19 19
Difficult to Open or Close 18 18
False Alarm 18 18
Output Problem 17 17
No Apparent Adverse Event 16 16
Noise, Audible 15 15
Fire 15 15
Filling Problem 14 14
Failure to Sense 14 14
Smoking 14 14
Appropriate Term/Code Not Available 14 14
Unintended Movement 13 13
Incorrect, Inadequate or Imprecise Result or Readings 13 13
Contamination /Decontamination Problem 12 12
Pressure Problem 12 12
Material Integrity Problem 11 11
Failure to Read Input Signal 11 11
Kinked 11 11
Loss of or Failure to Bond 10 10
Display or Visual Feedback Problem 10 10
Cut In Material 10 10
Material Deformation 10 10
Intermittent Loss of Power 9 9
Sparking 9 9
Material Separation 9 9
Device Inoperable 9 9
Corroded 9 9
Thermal Decomposition of Device 9 9
Burst Container or Vessel 9 9
Partial Blockage 8 8
Restricted Flow rate 8 8
Moisture Damage 8 8
Device Damaged Prior to Use 8 8
Tear, Rip or Hole in Device Packaging 8 8
Component Missing 8 8
Electrical /Electronic Property Problem 7 7
Degraded 6 6
Circuit Failure 6 6
No Device Output 6 6
Device Slipped 6 6
Inaudible or Unclear Audible Prompt/Feedback 6 6
Torn Material 6 6
Excessive Heating 6 6
Device Contamination with Chemical or Other Material 6 6
Failure to Select Signal 5 5
Split 5 5

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 3245 3245
No Patient Involvement 2943 2943
No Known Impact Or Consequence To Patient 1749 1749
No Consequences Or Impact To Patient 1317 1318
Low Oxygen Saturation 270 270
No Information 118 118
Insufficient Information 94 94
Death 38 38
Burn(s) 27 27
Respiratory Distress 14 14
Hypoxia 13 13
No Code Available 13 13
Bradycardia 11 11
Partial thickness (Second Degree) Burn 11 11
Cardiac Arrest 10 10
Dyspnea 9 9
Obstruction/Occlusion 8 8
Aspiration/Inhalation 7 7
Superficial (First Degree) Burn 7 7
Pneumonia 6 6
Discomfort 6 6
Burn, Thermal 5 5
Patient Problem/Medical Problem 5 5
Cancer 5 5
Cough 4 4
Unspecified Respiratory Problem 4 4
Viral Infection 4 4
Tachycardia 4 4
Airway Obstruction 4 4
Erythema 3 3
Complaint, Ill-Defined 3 3
Full thickness (Third Degree) Burn 3 3
Respiratory Arrest 3 3
Decreased Respiratory Rate 2 2
Increased Respiratory Rate 2 2
Injury 2 2
Pressure Sores 2 2
Distress 2 2
Ventilator Dependent 2 2
Pneumothorax 2 2
Cyanosis 2 2
Unspecified Infection 2 2
Inflammation 1 1
Myocardial Infarction 1 1
Neurological Deficit/Dysfunction 1 1
Pain 1 1
Asthma 1 1
Bacterial Infection 1 1
Skin Erosion 1 1
Swelling 1 1
Virus 1 1
Burning Sensation 1 1
Chronic Obstructive Pulmonary Disease (COPD) 1 1
Fever 1 1
Hemorrhage/Bleeding 1 1
Hyperventilation 1 1
Low Blood Pressure/ Hypotension 1 1
Hypothermia 1 1
Hypoventilation 1 1
Hypovolemic Shock 1 1
Arrhythmia 1 1
Abnormal Blood Gases 1 1
Abrasion 1 1
Adult Respiratory Distress Syndrome 1 1
Stroke/CVA 1 1
Chest Pain 1 1
Resuscitation 1 1
Respiratory Tract Infection 1 1
Irritability 1 1
Chest Tightness/Pressure 1 1
Nasal Obstruction 1 1
Respiratory Failure 1 1
Therapeutic Response, Decreased 1 1
Inadequate Pain Relief 1 1
Inadequate Osseointegration 1 1
Fibrosis 1 1
Underdose 1 1
Confusion/ Disorientation 1 1
Electric Shock 1 1
Missed Dose 1 1
Chemical Exposure 1 1
Blood Loss 1 1
Vitrectomy 1 1
Respiratory Insufficiency 1 1
Epistaxis 1 1
Multiple Organ Failure 1 1
Unspecified Kidney or Urinary Problem 1 1
Blister 1 1
Skin Inflammation/ Irritation 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 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 Telefelx Medical II Mar-09-2010
5 Teleflex Medical II Dec-15-2015
6 Teleflex Medical II Apr-30-2015
7 Teleflex Medical II Feb-12-2015
8 Teleflex Medical II Jul-23-2014
9 Teleflex Medical II Jul-07-2014
10 Teleflex Medical II Jul-19-2012
11 Teleflex Medical II Jul-12-2011
12 Teleflex Medical I Aug-13-2010
13 Vapotherm II Mar-17-2023
14 Vapotherm, Inc. II Sep-25-2014
15 Vyaire Medical I Jan-24-2018
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