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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
DRAEGERWERK AG & CO. KGAA
  SUBSTANTIALLY EQUIVALENT 1
FLEXICARE MEDICAL LIMITED
  SUBSTANTIALLY EQUIVALENT 1
FLEXICARE MEDICAL LTD.
  SUBSTANTIALLY EQUIVALENT 1
PLASTIFLEX GROUP NV
  SUBSTANTIALLY EQUIVALENT 1
RESPIRONICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
  1.  K140424  RESPIRONICS REUSABLE HEATED TUBING
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 103 103
2019 134 134
2020 123 123
2021 124 124
2022 152 152
2023 123 123
2024 45 45

Device Problems MDRs with this Device Problem Events in those MDRs
Leak/Splash 392 392
Crack 354 354
Insufficient Heating 159 159
Gas/Air Leak 152 152
Break 131 131
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
Connection Problem 43 43
Therapeutic or Diagnostic Output Failure 42 42
Moisture or Humidity Problem 41 41
Material Split, Cut or Torn 39 39
Device Issue 34 34
Melted 30 30
Loose or Intermittent Connection 29 29
Device Displays Incorrect Message 28 28
Air Leak 23 23
Fluid/Blood Leak 21 21
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
Degraded 12 12
Failure to Power Up 11 11
Use of Device Problem 11 11
Device Slipped 10 10
Adverse Event Without Identified Device or Use Problem 10 10
Device Handling 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
Ambient Temperature Problem 6 6
Manufacturing, Packaging or Shipping Problem 6 6
Material Deformation 6 6
Material Integrity Problem 6 6
Fitting Problem 6 6
Material Perforation 6 6
Split 5 5
Decrease in Pressure 5 5
Misconnection 4 4
Component Falling 4 4
Thermal Decomposition of Device 4 4
Component Missing 4 4
Improper or Incorrect Procedure or Method 4 4
Output Problem 4 4
Infusion or Flow Problem 4 4
Physical Property Issue 3 3
Torn Material 3 3
Device Fell 3 3
Device Inoperable 3 3
Failure to Disconnect 3 3
Sparking 3 3
Overfill 3 3
Obstruction of Flow 3 3
Circuit Failure 3 3
Corroded 3 3
Partial Blockage 3 3
Material Discolored 3 3
Moisture Damage 3 3
Fire 3 3
Misassembled 2 2
Increase in Pressure 2 2
Fracture 2 2
Mechanical Problem 2 2
Complete Blockage 2 2
Device Alarm System 2 2
Failure to Deliver 2 2
Smoking 2 2
Device Stops Intermittently 2 2
Protective Measures Problem 2 2
Misassembled During Installation 2 2
Appropriate Term/Code Not Available 2 2
Unintended Movement 2 2
Material Twisted/Bent 2 2
No Flow 2 2
Mechanics Altered 2 2
Material Protrusion/Extrusion 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
Contamination /Decontamination Problem 1 1
Compatibility Problem 1 1
Human-Device Interface Problem 1 1
Improper Device Output 1 1
Material Torqued 1 1
Mechanical Jam 1 1
Installation-Related Problem 1 1
Ventilation Problem in Device Environment 1 1
Misassembly by Users 1 1
Positioning Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 462 462
No Clinical Signs, Symptoms or Conditions 454 454
No Patient Involvement 428 428
No Consequences Or Impact To Patient 291 291
Low Oxygen Saturation 53 53
No Information 30 30
No Code Available 8 8
Bradycardia 7 7
Insufficient Information 6 6
Tachycardia 5 5
Hypoxia 3 3
Cardiac Arrest 3 3
Increased Respiratory Rate 3 3
Hypoventilation 2 2
Patient Problem/Medical Problem 2 2
Full thickness (Third Degree) Burn 2 2
Injury 2 2
Burn(s) 2 2
Aspiration/Inhalation 2 2
Burning Sensation 2 2
Respiratory Distress 2 2
Scar Tissue 1 1
Unspecified Infection 1 1
Laceration(s) 1 1
Pneumothorax 1 1
Pulmonary Edema 1 1
Exposure to Body Fluids 1 1
Death 1 1
Dyspnea 1 1
Fever 1 1
High Blood Pressure/ Hypertension 1 1
Extubate 1 1
Irritability 1 1
Increased Peak Expiratory Flow rate 1 1
Needle Stick/Puncture 1 1
Respiratory Failure 1 1
Therapeutic Response, Decreased 1 1
Partial thickness (Second Degree) Burn 1 1
Alteration In Body Temperature 1 1
Fluid Discharge 1 1
Unspecified Respiratory Problem 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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