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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 3
FISHER & PAYKEL HEALTHCARE LTD
  SUBSTANTIALLY EQUIVALENT 6
FISHER & PAYKEL HEALTHCARE LTD.
  SUBSTANTIALLY EQUIVALENT 1
FISHER &PAYKEL HEALTHCARE LTD.
  SUBSTANTIALLY EQUIVALENT 1
HOMETA INC
  SUBSTANTIALLY EQUIVALENT 1
INVENT MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
MEDLINE INDUSTRIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
PERMA PURE LLC
  SUBSTANTIALLY EQUIVALENT 1
TELESAIR, INC.
  SUBSTANTIALLY EQUIVALENT 1
  1.  K223863  BONHAWA Respiratory Humidifier
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 246 246

Device Problems MDRs with this Device Problem Events in those MDRs
No Audible Alarm 3116 3116
Material Split, Cut or Torn 448 448
Leak/Splash 387 387
Crack 365 365
Break 334 334
Insufficient Heating 307 307
Fluid/Blood Leak 305 305
Failure to Power Up 186 186
Detachment of Device or Device Component 152 152
Device Alarm System 135 135
Complete Loss of Power 83 83
Melted 81 81
Defective Alarm 77 77
Gas/Air Leak 75 75
Mechanical Problem 63 63
Adverse Event Without Identified Device or Use Problem 61 61
Power Problem 58 58
Disconnection 57 57
Temperature Problem 51 51
Overfill 48 48
Therapeutic or Diagnostic Output Failure 32 32
Overheating of Device 30 30
Material Puncture/Hole 29 29
Use of Device Problem 27 27
Insufficient Information 27 27
No Audible Prompt/Feedback 27 27
Defective Component 26 26
Obstruction of Flow 25 25
Infusion or Flow Problem 25 25
Improper Flow or Infusion 19 19
Stretched 19 19
Unexpected Shutdown 19 19
Defective Device 18 18
Device Displays Incorrect Message 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
Moisture or Humidity Problem 15 15
Misconnection 15 15
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
Fire 13 13
Loss of Power 12 12
Contamination /Decontamination Problem 12 12
Failure to Deliver 12 12
Unintended Movement 12 12
Material Integrity Problem 11 11
Device Emits Odor 11 11
Failure to Read Input Signal 11 11
Device Handling Problem 10 10
Device Sensing Problem 10 10
Failure of Device to Self-Test 9 9
Intermittent Loss of Power 9 9
Corroded 9 9
False Alarm 8 8
Noise, Audible 8 8
Sparking 8 8
Display or Visual Feedback Problem 7 7
Filling Problem 7 7
Smoking 7 7
Failure to Sense 6 6
Degraded 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
Electrical /Electronic Property Problem 5 5
Thermal Decomposition of Device 5 5
Failure to Select Signal 5 5
Fitting Problem 5 5
Device Slipped 4 4
Material Separation 4 4
Complete Blockage 4 4
Partial Blockage 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
Physical Resistance/Sticking 3 3
Appropriate Term/Code Not Available 3 3
Loss of or Failure to Bond 3 3
No Device Output 3 3
Incorrect Measurement 3 3
Audible Prompt/Feedback Problem 3 3
Incomplete or Inadequate Connection 2 2
Hole In Material 2 2
Product Quality Problem 2 2
Failure to Reset 2 2
Short Fill 2 2
Inappropriate Audible Prompt/Feedback 2 2
Device Stops Intermittently 2 2
Low Audible Alarm 2 2
Air Leak 2 2
Burst Container or Vessel 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 3286 3286
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 230 230
Insufficient Information 95 95
Death 25 25
Burn(s) 15 15
No Information 14 14
Hypoxia 12 12
Cardiac Arrest 9 9
Bradycardia 9 9
Partial thickness (Second Degree) Burn 8 8
Respiratory Distress 7 7
Obstruction/Occlusion 6 6
Superficial (First Degree) Burn 5 5
Cancer 4 4
Cough 4 4
Unspecified Respiratory Problem 4 4
Pneumonia 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
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
Blister 2 2
Pressure Sores 2 2
Distress 2 2
Nasal Obstruction 1 1
Complaint, Ill-Defined 1 1
Inadequate Pain Relief 1 1
Ventilator Dependent 1 1
Irritability 1 1
Virus 1 1
Burning Sensation 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
Skin Inflammation/ Irritation 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Respiratory Insufficiency 1 1
Unspecified Kidney or Urinary Problem 1 1
Epistaxis 1 1
Fibrosis 1 1
Electric Shock 1 1
Blood Loss 1 1
Respiratory Failure 1 1
Decreased Respiratory Rate 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 Vapotherm II Mar-17-2023
5 Vyaire Medical I Jan-24-2018
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