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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device heater, breathing system w/wo controller (not humidifier or nebulizer
Regulation Description Breathing system heater.
Product CodeBZE
Regulation Number 868.5270
Device Class 2


Premarket Reviews
ManufacturerDecision
CAREFUSION
  SUBSTANTIALLY EQUIVALENT 1
CAREFUSION INC
  SUBSTANTIALLY EQUIVALENT 2
FLEXICARE MEDICAL LIMITED
  SUBSTANTIALLY EQUIVALENT 1
FLEXICARE MEDICAL LTD.
  SUBSTANTIALLY EQUIVALENT 1
PLASTIFLEX GROUP NV
  SUBSTANTIALLY EQUIVALENT 1
RESPIRONICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
SUNSET HEALTHCARE SOLUTIONS, INC.
  SUBSTANTIALLY EQUIVALENT 1
TELEFLEX MEDICAL, INC
  SUBSTANTIALLY EQUIVALENT 1
  1.  K173280  Neonatal ConchaSmart Breathing Circuits
VYAIRE MEDICAL
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 338 338
2015 155 155
2016 212 212
2017 209 209
2018 102 102
2019 134 134
2020 123 123
2021 108 108

Device Problems MDRs with this Device Problem Events in those MDRs
Crack 312 312
Leak/Splash 231 231
Insufficient Heating 158 158
Disconnection 109 109
Break 103 103
Temperature Problem 94 94
Device Operates Differently Than Expected 84 84
Gas Leak 67 67
Hole In Material 49 49
Moisture or Humidity Problem 40 40
Failure of Device to Self-Test 38 38
Connection Problem 34 34
Device Issue 34 34
Melted 29 29
Device Displays Incorrect Message 28 28
Loose or Intermittent Connection 25 25
Air Leak 23 23
Incorrect, Inadequate or Imprecise Resultor Readings 21 21
Therapeutic or Diagnostic Output Failure 18 18
Detachment Of Device Component 17 17
Detachment of Device or Device Component 15 15
Power Problem 13 13
Material Separation 12 12
Material Puncture/Hole 12 12
Device Damaged Prior to Use 12 12
Failure to Power Up 11 11
Fluid Leak 10 10
Adverse Event Without Identified Device or Use Problem 10 10
Device Handling Problem 9 9
Device Slipped 9 9
Cut In Material 9 9
Use of Device Problem 8 8
Overheating of Device 8 8
No Apparent Adverse Event 8 8
Insufficient Information 6 6
Pressure Problem 6 6
Manufacturing, Packaging or Shipping Problem 6 6
Material Integrity Problem 6 6
Fitting Problem 6 6
Material Perforation 6 6
Ambient Temperature Problem 6 6
Split 5 5
Decrease in Pressure 5 5
Component Falling 4 4
Degraded 4 4
Material Split, Cut or Torn 4 4
Device Fell 3 3
Output Problem 3 3
Physical Property Issue 3 3
Torn Material 3 3
Partial Blockage 3 3
Thermal Decomposition of Device 3 3
Circuit Failure 3 3
Moisture Damage 3 3
Sparking 3 3
Improper or Incorrect Procedure or Method 3 3
Device Inoperable 3 3
Smoking 2 2
Device Stops Intermittently 2 2
Failure to Deliver 2 2
Device Operational Issue 2 2
Obstruction of Flow 2 2
Fire 2 2
Increase in Pressure 2 2
Fracture 2 2
Mechanical Problem 2 2
Material Discolored 2 2
Unintended Movement 2 2
No Flow 2 2
Material Protrusion/Extrusion 2 2
Mechanics Altered 2 2
Improper Flow or Infusion 2 2
Compatibility Problem 1 1
Infusion or Flow Problem 1 1
Installation-Related Problem 1 1
Human-Device Interface Problem 1 1
Improper Device Output 1 1
Material Deformation 1 1
Material Torqued 1 1
Mechanical Jam 1 1
No Pressure 1 1
Positioning Problem 1 1
Protective Measures Problem 1 1
Ventilation Problem in Device Environment 1 1
Misassembly by Users 1 1
Appropriate Term/Code Not Available 1 1
Data Problem 1 1
Intermittent Loss of Power 1 1
Unexpected Shutdown 1 1
Separation Problem 1 1
Misassembled During Installation 1 1
Patient Device Interaction Problem 1 1
Component Misassembled 1 1
Material Disintegration 1 1
Fail-Safe Design Failure 1 1
Disassembly 1 1
Complete Blockage 1 1
Charred 1 1
Device Alarm System 1 1
False Alarm 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 462 462
No Patient Involvement 428 428
No Consequences Or Impact To Patient 291 291
No Clinical Signs, Symptoms or Conditions 136 136
Low Oxygen Saturation 41 41
No Information 30 30
No Code Available 8 8
Bradycardia 7 7
Tachycardia 5 5
Insufficient Information 3 3
Increased Respiratory Rate 3 3
Cardiac Arrest 3 3
Burn(s) 2 2
Respiratory Distress 2 2
Hypoventilation 2 2
Injury 2 2
Full thickness (Third Degree) Burn 2 2
Patient Problem/Medical Problem 2 2
Partial thickness (Second Degree) Burn 1 1
Extubate 1 1
Irritability 1 1
Increased Peak Expiratory Flow rate 1 1
Needle Stick/Puncture 1 1
Alteration In Body Temperature 1 1
Fluid Discharge 1 1
Hypoxia 1 1
Unspecified Infection 1 1
Pneumothorax 1 1
Pulmonary Edema 1 1
Scar Tissue 1 1
Therapeutic Response, Decreased 1 1
Aspiration/Inhalation 1 1
Exposure to Body Fluids 1 1
Death 1 1
Dyspnea 1 1
Fever 1 1
High Blood Pressure/ Hypertension 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Carefusion 2200 Inc II Sep-23-2014
2 Teleflex Medical I Jul-15-2019
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