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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 8
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
INVENT MEDICAL CORPORATION
  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
SALTER LABS, ARVIN FACILITY
  SUBSTANTIALLY EQUIVALENT 1
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 710 710
2024 331 331

Device Problems MDRs with this Device Problem Events in those MDRs
No Audible Alarm 4403 4403
Leak/Splash 652 652
Crack 542 542
Break 460 460
Material Split, Cut or Torn 455 455
Fluid/Blood Leak 424 424
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 169 169
Melted 117 117
Defective Alarm 96 96
Overheating of Device 93 93
Complete Loss of Power 83 83
Gas/Air Leak 79 79
Disconnection 78 78
Adverse Event Without Identified Device or Use Problem 72 72
Mechanical Problem 67 67
Device Displays Incorrect Message 57 57
Overfill 56 56
Device Issue 46 46
Insufficient Information 38 38
No Flow 36 36
Moisture or Humidity Problem 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
Material Puncture/Hole 29 29
Device Handling Problem 29 29
Defective Component 28 28
Infusion or Flow Problem 28 28
Device Sensing Problem 28 28
No Audible Prompt/Feedback 27 27
Obstruction of Flow 27 27
Protective Measures Problem 26 26
Improper or Incorrect Procedure or Method 25 25
Improper Flow or Infusion 24 24
Device Stops Intermittently 24 24
Air Leak 23 23
No Display/Image 22 22
Fitting Problem 22 22
Stretched 21 21
Detachment Of Device Component 20 20
Loss of Power 20 20
Defective Device 20 20

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 3371 3371
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 278 278
No Information 118 118
Insufficient Information 98 98
Death 38 38
Burn(s) 27 27
Respiratory Distress 14 14
Hypoxia 14 14
No Code Available 13 13
Partial thickness (Second Degree) Burn 12 12
Bradycardia 11 11
Cardiac Arrest 10 10
Dyspnea 9 9
Obstruction/Occlusion 8 8
Superficial (First Degree) Burn 7 7
Aspiration/Inhalation 7 7
Pneumonia 6 6
Discomfort 6 6
Patient Problem/Medical Problem 5 5
Burn, Thermal 5 5
Cancer 5 5
Tachycardia 4 4
Viral Infection 4 4
Airway Obstruction 4 4
Cough 4 4
Unspecified Respiratory Problem 4 4
Complaint, Ill-Defined 3 3
Full thickness (Third Degree) Burn 3 3
Respiratory Arrest 3 3
Erythema 3 3
Increased Respiratory Rate 2 2
Injury 2 2
Pressure Sores 2 2
Blister 2 2
Ventilator Dependent 2 2
Decreased Respiratory Rate 2 2
Pneumothorax 2 2
Distress 2 2
Unspecified Infection 2 2
Cyanosis 2 2
Therapeutic Response, Decreased 1 1
Underdose 1 1
Myocardial Infarction 1 1
Hyperventilation 1 1
Bacterial Infection 1 1
Hemorrhage/Bleeding 1 1
Inadequate Pain Relief 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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