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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
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
2017 209 209
2018 102 102
2019 134 134
2020 123 123
2021 124 124
2022 152 152

Device Problems MDRs with this Device Problem Events in those MDRs
Leak/Splash 202 202
Crack 169 169
Gas/Air Leak 132 132
Insufficient Heating 110 110
Disconnection 73 73
Break 66 66
Temperature Problem 56 56
Therapeutic or Diagnostic Output Failure 42 42
Connection Problem 31 31
Failure of Device to Self-Test 30 30
Material Split, Cut or Torn 22 22
Moisture or Humidity Problem 20 20
Loose or Intermittent Connection 19 19
Incorrect, Inadequate or Imprecise Result or Readings 19 19
Material Puncture/Hole 15 15
Detachment of Device or Device Component 15 15
Melted 9 9
Use of Device Problem 8 8
No Apparent Adverse Event 8 8
Device Handling Problem 7 7
Device Issue 7 7
Material Separation 7 7
Material Perforation 6 6
Air Leak 6 6
Degraded 6 6
Adverse Event Without Identified Device or Use Problem 6 6
Ambient Temperature Problem 6 6
Manufacturing, Packaging or Shipping Problem 6 6
Split 5 5
Device Displays Incorrect Message 4 4
Obstruction of Flow 4 4
Infusion or Flow Problem 4 4
Output Problem 4 4
Hole In Material 4 4
Thermal Decomposition of Device 4 4
Fire 3 3
Fluid/Blood Leak 3 3
Overheating of Device 3 3
Material Integrity Problem 3 3
Fitting Problem 3 3
Improper or Incorrect Procedure or Method 3 3
Device Operates Differently Than Expected 3 3
Pressure Problem 3 3
Device Fell 3 3
Insufficient Information 2 2
Appropriate Term/Code Not Available 2 2
Protective Measures Problem 2 2
Power Problem 2 2
Misassembled During Installation 2 2
Failure to Disconnect 2 2
Decrease in Pressure 2 2
Misassembled 2 2
Misconnection 2 2
Device Slipped 2 2
Device Inoperable 2 2
Fracture 2 2
Material Discolored 2 2
Device Alarm System 2 2
Detachment Of Device Component 2 2
Component Falling 1 1
Charred 1 1
Complete Blockage 1 1
Material Disintegration 1 1
Inadequacy of Device Shape and/or Size 1 1
Device Damaged Prior to Use 1 1
Defective Component 1 1
Component Missing 1 1
Mechanical Problem 1 1
Product Quality Problem 1 1
Sparking 1 1
Device-Device Incompatibility 1 1
Device Dislodged or Dislocated 1 1
Insufficient Flow or Under Infusion 1 1
Overfill 1 1
Cut In Material 1 1
Incorrect Or Inadequate Test Results 1 1
Dent in Material 1 1
Deformation Due to Compressive Stress 1 1
Installation-Related Problem 1 1
Human-Device Interface Problem 1 1
Improper Flow or Infusion 1 1
Material Twisted/Bent 1 1
Mechanical Jam 1 1
Mechanics Altered 1 1
Physical Property Issue 1 1
Material Deformation 1 1
Unintended Movement 1 1
Misassembly by Users 1 1
Patient Device Interaction Problem 1 1
Component Misassembled 1 1
Intermittent Loss of Power 1 1
Unexpected Shutdown 1 1
Separation Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 296 296
No Patient Involvement 239 239
No Known Impact Or Consequence To Patient 152 152
No Consequences Or Impact To Patient 134 134
Low Oxygen Saturation 29 29
Bradycardia 7 7
Insufficient Information 5 5
Cardiac Arrest 3 3
Hypoventilation 2 2
Hypoxia 2 2
Burn(s) 2 2
No Code Available 2 2
Full thickness (Third Degree) Burn 1 1
Respiratory Failure 1 1
Increased Respiratory Rate 1 1
Irritability 1 1
Increased Peak Expiratory Flow rate 1 1
Aspiration/Inhalation 1 1
Exposure to Body Fluids 1 1
Pneumothorax 1 1
Death 1 1
Dyspnea 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Teleflex Medical I Jul-15-2019
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