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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
DRAEGERWERK AG & CO. KGAA
  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
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 299 299
Crack 197 197
Gas/Air Leak 151 151
Insufficient Heating 111 111
Disconnection 73 73
Break 69 69
Temperature Problem 56 56
Therapeutic or Diagnostic Output Failure 42 42
Material Split, Cut or Torn 39 39
Connection Problem 33 33
Failure of Device to Self-Test 30 30
Loose or Intermittent Connection 23 23
Moisture or Humidity Problem 20 20
Incorrect, Inadequate or Imprecise Result or Readings 19 19
Material Puncture/Hole 15 15
Detachment of Device or Device Component 15 15
Fluid/Blood Leak 14 14
Degraded 12 12
Use of Device Problem 10 10
Melted 10 10
No Apparent Adverse Event 8 8
Device Handling Problem 7 7
Material Separation 7 7
Device Issue 7 7
Ambient Temperature Problem 6 6
Material Perforation 6 6
Adverse Event Without Identified Device or Use Problem 6 6
Manufacturing, Packaging or Shipping Problem 6 6
Material Deformation 6 6
Air Leak 6 6
Split 5 5
Device Displays Incorrect Message 4 4
Component Missing 4 4
Output Problem 4 4
Infusion or Flow Problem 4 4
Thermal Decomposition of Device 4 4
Misconnection 4 4
Hole In Material 4 4
Overheating of Device 3 3
Improper or Incorrect Procedure or Method 3 3
Corroded 3 3
Fire 3 3
Device Operates Differently Than Expected 3 3
Material Integrity Problem 3 3
Fitting Problem 3 3
Obstruction of Flow 3 3
Failure to Disconnect 3 3
Device Fell 3 3
Pressure Problem 3 3
Protective Measures Problem 2 2
Power Problem 2 2
Insufficient Information 2 2
Appropriate Term/Code Not Available 2 2
Misassembled During Installation 2 2
Overfill 2 2
Material Twisted/Bent 2 2
Fracture 2 2
Material Discolored 2 2
Device Alarm System 2 2
Detachment Of Device Component 2 2
Device Slipped 2 2
Device Inoperable 2 2
Decrease in Pressure 2 2
Misassembled 2 2
Mechanical Problem 1 1
Insufficient Flow or Under Infusion 1 1
Inadequacy of Device Shape and/or Size 1 1
Product Quality Problem 1 1
Component Falling 1 1
Charred 1 1
Complete Blockage 1 1
Material Disintegration 1 1
Mechanical Jam 1 1
Mechanics Altered 1 1
Physical Property Issue 1 1
Device-Device Incompatibility 1 1
Device Dislodged or Dislocated 1 1
Installation-Related Problem 1 1
Human-Device Interface Problem 1 1
Improper Flow or Infusion 1 1
Sparking 1 1
Deformation Due to Compressive Stress 1 1
Contamination /Decontamination Problem 1 1
Cut In Material 1 1
Incorrect Or Inadequate Test Results 1 1
Dent in Material 1 1
Device Damaged Prior to Use 1 1
Defective Component 1 1
Unintended Movement 1 1
Misassembly by Users 1 1
Intermittent Loss of Power 1 1
Unexpected Shutdown 1 1
Separation Problem 1 1
Noise, Audible 1 1
Patient Device Interaction Problem 1 1
Component Misassembled 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 454 454
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 35 35
Bradycardia 7 7
Insufficient Information 6 6
Cardiac Arrest 3 3
Hypoxia 3 3
Burn(s) 2 2
Hypoventilation 2 2
Burning Sensation 2 2
No Code Available 2 2
Unspecified Respiratory Problem 1 1
Irritability 1 1
Increased Peak Expiratory Flow rate 1 1
Respiratory Failure 1 1
Increased Respiratory Rate 1 1
Full thickness (Third Degree) Burn 1 1
Aspiration/Inhalation 1 1
Exposure to Body Fluids 1 1
Laceration(s) 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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