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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 2
  1.  K162553  AirSpiral Heated Breathing Tube
  2.  K220703  F&P 950 Respiratory Humidifier
FISHER & PAYKEL HEALTHCARE LTD
  SUBSTANTIALLY EQUIVALENT 5
FISHER & PAYKEL HEALTHCARE LTD.
  SUBSTANTIALLY EQUIVALENT 1
FISHER &PAYKEL HEALTHCARE LTD.
  SUBSTANTIALLY EQUIVALENT 1
HOMETA INC
  SUBSTANTIALLY EQUIVALENT 1
MEDLINE INDUSTRIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
PERMA PURE LLC
  SUBSTANTIALLY EQUIVALENT 1
TELESAIR, INC.
  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
VYAIRE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2018 918 918
2019 894 894
2020 1188 1188
2021 1508 1508
2022 749 749
2023 704 704
2024 29 29

Device Problems MDRs with this Device Problem Events in those MDRs
No Audible Alarm 3049 3049
Material Split, Cut or Torn 418 418
Leak/Splash 352 352
Crack 351 351
Break 331 331
Insufficient Heating 307 307
Fluid/Blood Leak 287 287
Failure to Power Up 186 186
Detachment of Device or Device Component 139 139
Device Alarm System 132 132
Complete Loss of Power 83 83
Gas/Air Leak 72 72
Melted 71 71
Defective Alarm 67 67
Mechanical Problem 58 58
Power Problem 58 58
Adverse Event Without Identified Device or Use Problem 57 57
Disconnection 53 53
Temperature Problem 51 51
Overfill 47 47
Therapeutic or Diagnostic Output Failure 32 32
Overheating of Device 30 30
Material Puncture/Hole 28 28
No Audible Prompt/Feedback 27 27
Defective Component 26 26
Use of Device Problem 26 26
Infusion or Flow Problem 25 25
Insufficient Information 24 24
Obstruction of Flow 24 24
Improper Flow or Infusion 19 19
Unexpected Shutdown 19 19
Defective Device 18 18
Device Displays Incorrect Message 18 18
Stretched 18 18
Improper or Incorrect Procedure or Method 17 17
Output Problem 16 16
No Apparent Adverse Event 16 16
No Flow 15 15
Protective Measures Problem 15 15
Misconnection 15 15
Moisture or Humidity Problem 14 14
Difficult to Open or Close 14 14
Connection Problem 14 14
Loose or Intermittent Connection 13 13
Incorrect, Inadequate or Imprecise Result or Readings 13 13
Loss of Power 12 12
Fire 12 12
Contamination /Decontamination Problem 12 12
Failure to Deliver 12 12
Material Integrity Problem 11 11
Device Emits Odor 11 11
Failure to Read Input Signal 11 11
Unintended Movement 10 10
Device Handling Problem 10 10
Device Sensing Problem 10 10
Failure of Device to Self-Test 9 9
Intermittent Loss of Power 9 9
Noise, Audible 8 8
Sparking 8 8
False Alarm 8 8
Filling Problem 7 7
Corroded 7 7
Display or Visual Feedback Problem 7 7
Degraded 6 6
Failure to Sense 6 6
Smoking 6 6
Component Missing 6 6
Inaudible or Unclear Audible Prompt/Feedback 6 6
Excessive Heating 6 6
Device Issue 5 5
Material Deformation 5 5
Fitting Problem 5 5
Failure to Select Signal 5 5
Electrical /Electronic Property Problem 5 5
Thermal Decomposition of Device 5 5
Device Slipped 4 4
Material Separation 4 4
Device Damaged Prior to Use 4 4
Ambient Temperature Problem 4 4
Human-Device Interface Problem 3 3
Device Operates Differently Than Expected 3 3
Material Twisted/Bent 3 3
Audible Prompt/Feedback Problem 3 3
Appropriate Term/Code Not Available 3 3
Physical Resistance/Sticking 3 3
No Device Output 3 3
Incorrect Measurement 3 3
Loss of or Failure to Bond 3 3
Complete Blockage 3 3
Air Leak 2 2
Burst Container or Vessel 2 2
Low Audible Alarm 2 2
No Display/Image 2 2
Unintended Ejection 2 2
Hole In Material 2 2
Product Quality Problem 2 2
Failure to Reset 2 2
Short Fill 2 2
Device Stops Intermittently 2 2
Device Fell 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 3095 3095
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 219 219
Insufficient Information 88 88
Death 25 25
Burn(s) 15 15
No Information 14 14
Bradycardia 9 9
Hypoxia 8 8
Cardiac Arrest 7 7
Respiratory Distress 7 7
Partial thickness (Second Degree) Burn 7 7
Obstruction/Occlusion 6 6
Superficial (First Degree) Burn 5 5
Pneumonia 4 4
Cough 4 4
Viral Infection 4 4
Tachycardia 4 4
Airway Obstruction 4 4
Dyspnea 4 4
Aspiration/Inhalation 3 3
Discomfort 3 3
Respiratory Arrest 3 3
Unspecified Respiratory Problem 3 3
Cancer 3 3
Full thickness (Third Degree) Burn 3 3
Patient Problem/Medical Problem 3 3
Increased Respiratory Rate 2 2
Burn, Thermal 2 2
No Code Available 2 2
Pressure Sores 2 2
Distress 1 1
Nasal Obstruction 1 1
Complaint, Ill-Defined 1 1
Inadequate Pain Relief 1 1
Ventilator Dependent 1 1
Virus 1 1
Chronic Obstructive Pulmonary Disease (COPD) 1 1
Skin Erosion 1 1
Swelling 1 1
Abrasion 1 1
Asthma 1 1
Bacterial Infection 1 1
Arrhythmia 1 1
Stroke/CVA 1 1
Cyanosis 1 1
Erythema 1 1
Fever 1 1
Hyperventilation 1 1
Low Blood Pressure/ Hypotension 1 1
Hypothermia 1 1
Unspecified Infection 1 1
Inflammation 1 1
Myocardial Infarction 1 1
Neurological Deficit/Dysfunction 1 1
Pain 1 1
Fibrosis 1 1
Electric Shock 1 1
Blood Loss 1 1
Respiratory Failure 1 1
Blister 1 1
Skin Inflammation/ Irritation 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Respiratory Insufficiency 1 1
Epistaxis 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 Vapotherm II Mar-17-2023
4 Vyaire Medical I Jan-24-2018
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