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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
  1.  K160540  FLEXICARE NEONATAL HEATED WIRE BREATHING SYSTEM
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
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 29 29

Device Problems MDRs with this Device Problem Events in those MDRs
Crack 318 318
Leak/Splash 240 240
Insufficient Heating 158 158
Disconnection 111 111
Break 110 110
Temperature Problem 94 94
Gas Leak 85 85
Device Operates Differently Than Expected 84 84
Hole In Material 49 49
Failure of Device to Self-Test 46 46
Moisture or Humidity Problem 40 40
Connection Problem 40 40
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 21 21
Detachment Of Device Component 17 17
Detachment of Device or Device Component 15 15
Power Problem 13 13
Material Puncture/Hole 12 12
Material Separation 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
Use of Device Problem 9 9
Device Slipped 9 9
Cut In Material 9 9
Overheating of Device 8 8
No Apparent Adverse Event 8 8
Material Split, Cut or Torn 7 7
Insufficient Information 6 6
Manufacturing, Packaging or Shipping Problem 6 6
Pressure Problem 6 6
Material Integrity Problem 6 6
Ambient Temperature Problem 6 6
Fitting Problem 6 6
Material Perforation 6 6
Split 5 5
Decrease in Pressure 5 5
Component Falling 4 4
Degraded 4 4
Thermal Decomposition of Device 4 4
Improper or Incorrect Procedure or Method 4 4
Output Problem 4 4
Physical Property Issue 3 3
Torn Material 3 3
Infusion or Flow Problem 3 3
Device Fell 3 3
Device Inoperable 3 3
Sparking 3 3
Circuit Failure 3 3
Partial Blockage 3 3
Fire 3 3
Moisture Damage 3 3
Misconnection 2 2
Increase in Pressure 2 2
Fracture 2 2
Mechanical Problem 2 2
Material Discolored 2 2
Failure to Deliver 2 2
Overfill 2 2
Obstruction of Flow 2 2
Smoking 2 2
Device Stops Intermittently 2 2
Appropriate Term/Code Not Available 2 2
Misassembled During Installation 2 2
Improper Flow or Infusion 2 2
Material Protrusion/Extrusion 2 2
Device Operational Issue 2 2
Unintended Movement 2 2
Protective Measures Problem 2 2
Mechanics Altered 2 2
No Flow 2 2
No Pressure 1 1
Material Deformation 1 1
Positioning Problem 1 1
Ventilation Problem in Device Environment 1 1
Misassembly by Users 1 1
Device Damaged by Another Device 1 1
Device-Device Incompatibility 1 1
Device Dislodged or Dislocated 1 1
Human-Device Interface Problem 1 1
Improper Device Output 1 1
Material Torqued 1 1
Material Twisted/Bent 1 1
Mechanical Jam 1 1
Compatibility Problem 1 1
Installation-Related Problem 1 1
Patient Device Interaction Problem 1 1
Component Misassembled 1 1
Data Problem 1 1
Intermittent Loss of Power 1 1
Unexpected Shutdown 1 1
Separation Problem 1 1
Tidal Volume Fluctuations 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 175 175
Low Oxygen Saturation 44 44
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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