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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
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 124 124
2022 152 152
2023 15 15

Device Problems MDRs with this Device Problem Events in those MDRs
Crack 327 327
Leak/Splash 305 305
Insufficient Heating 158 158
Gas/Air Leak 133 133
Break 128 128
Disconnection 113 113
Temperature Problem 94 94
Device Operates Differently Than Expected 84 84
Failure of Device to Self-Test 51 51
Hole In Material 49 49
Therapeutic or Diagnostic Output Failure 42 42
Moisture or Humidity Problem 41 41
Connection Problem 41 41
Device Issue 34 34
Melted 29 29
Device Displays Incorrect Message 28 28
Material Split, Cut or Torn 26 26
Loose or Intermittent Connection 25 25
Air Leak 23 23
Incorrect, Inadequate or Imprecise Result or Readings 21 21
Detachment Of Device Component 17 17
Detachment of Device or Device Component 17 17
Material Puncture/Hole 15 15
Power Problem 13 13
Material Separation 12 12
Device Damaged Prior to Use 12 12
Failure to Power Up 11 11
Fluid/Blood Leak 10 10
Device Slipped 10 10
Adverse Event Without Identified Device or Use Problem 10 10
Device Handling Problem 9 9
Use of Device Problem 9 9
Cut In Material 9 9
Overheating of Device 8 8
No Apparent Adverse Event 8 8
Insufficient Information 6 6
Pressure Problem 6 6
Material Integrity Problem 6 6
Ambient Temperature Problem 6 6
Manufacturing, Packaging or Shipping Problem 6 6
Degraded 6 6
Fitting Problem 6 6
Material Perforation 6 6
Split 5 5
Decrease in Pressure 5 5
Component Falling 4 4
Thermal Decomposition of Device 4 4
Obstruction of Flow 4 4
Improper or Incorrect Procedure or Method 4 4
Infusion or Flow Problem 4 4
Output Problem 4 4
Physical Property Issue 3 3
Torn Material 3 3
Device Fell 3 3
Sparking 3 3
Device Inoperable 3 3
Circuit Failure 3 3
Partial Blockage 3 3
Material Discolored 3 3
Fire 3 3
Moisture Damage 3 3
Misassembled 2 2
Misconnection 2 2
Increase in Pressure 2 2
Fracture 2 2
Mechanical Problem 2 2
Complete Blockage 2 2
Device Alarm System 2 2
Overfill 2 2
Component Missing 2 2
Failure to Deliver 2 2
Failure to Disconnect 2 2
Smoking 2 2
Device Stops Intermittently 2 2
Misassembled During Installation 2 2
Protective Measures Problem 2 2
Appropriate Term/Code Not Available 2 2
Unintended Movement 2 2
Material Protrusion/Extrusion 2 2
No Flow 2 2
Mechanics Altered 2 2
Improper Flow or Infusion 2 2
Device Operational Issue 2 2
Device Damaged by Another Device 1 1
Device-Device Incompatibility 1 1
Device Dislodged or Dislocated 1 1
Deformation Due to Compressive Stress 1 1
Compatibility Problem 1 1
Human-Device Interface Problem 1 1
Improper Device Output 1 1
Installation-Related Problem 1 1
Material Deformation 1 1
Material Torqued 1 1
Material Twisted/Bent 1 1
Mechanical Jam 1 1
Ventilation Problem in Device Environment 1 1
Misassembly by Users 1 1
Positioning Problem 1 1
No Pressure 1 1
Data Problem 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 Clinical Signs, Symptoms or Conditions 311 311
No Consequences Or Impact To Patient 291 291
Low Oxygen Saturation 47 47
No Information 30 30
No Code Available 8 8
Bradycardia 7 7
Insufficient Information 5 5
Tachycardia 5 5
Increased Respiratory Rate 3 3
Cardiac Arrest 3 3
Burn(s) 2 2
Aspiration/Inhalation 2 2
Respiratory Distress 2 2
Hypoventilation 2 2
Hypoxia 2 2
Injury 2 2
Patient Problem/Medical Problem 2 2
Full thickness (Third Degree) Burn 2 2
Alteration In Body Temperature 1 1
Fluid Discharge 1 1
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
Respiratory Failure 1 1
Unspecified Infection 1 1
Pneumothorax 1 1
Pulmonary Edema 1 1
Scar Tissue 1 1
Therapeutic Response, Decreased 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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