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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
  1.  K151303  AirLife Infant Heated Wire Circuit
CAREFUSION INC
  SUBSTANTIALLY EQUIVALENT 2
DRAEGERWERK AG & CO. KGAA
  SUBSTANTIALLY EQUIVALENT 1
EXCELERON MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
FLEXICARE MEDICAL LIMITED
  SUBSTANTIALLY EQUIVALENT 1
FLEXICARE MEDICAL LTD.
  SUBSTANTIALLY EQUIVALENT 1
MEDLINE INDUSTRIES, LP
  SUBSTANTIALLY EQUIVALENT 1
PLASTIFLEX GROUP NV
  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
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 124 124
2024 103 103

Device Problems MDRs with this Device Problem Events in those MDRs
Leak/Splash 368 368
Crack 319 319
Gas/Air Leak 177 177
Insufficient Heating 141 141
Disconnection 97 97
Temperature Problem 90 90
Break 88 88
Therapeutic or Diagnostic Output Failure 42 42
Connection Problem 41 41
Material Split, Cut or Torn 40 40
Moisture or Humidity Problem 35 35
Device Issue 34 34
Failure of Device to Self-Test 32 32
Loose or Intermittent Connection 31 31
Melted 23 23
Incorrect, Inadequate or Imprecise Result or Readings 21 21
Device Operates Differently Than Expected 20 20
Fluid/Blood Leak 17 17
Detachment of Device or Device Component 17 17
Hole In Material 15 15
Material Puncture/Hole 15 15
Air Leak 14 14
Detachment Of Device Component 14 14
Degraded 13 13
Use of Device Problem 11 11
Material Separation 10 10
Device Displays Incorrect Message 9 9
Device Handling Problem 9 9
Cut In Material 9 9
No Apparent Adverse Event 8 8
Adverse Event Without Identified Device or Use Problem 8 8
Mechanical Problem 6 6
Insufficient Information 6 6
Manufacturing, Packaging or Shipping Problem 6 6
Ambient Temperature Problem 6 6
Material Deformation 6 6
Material Perforation 6 6
Fitting Problem 6 6
Failure to Power Up 6 6
Split 5 5
Overheating of Device 5 5
Power Problem 5 5
Material Integrity Problem 5 5
Device Slipped 5 5
Component Missing 5 5
Output Problem 4 4
Pressure Problem 4 4
Misconnection 4 4
Infusion or Flow Problem 4 4
Thermal Decomposition of Device 4 4

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 509 509
No Known Impact Or Consequence To Patient 305 305
No Patient Involvement 305 305
No Consequences Or Impact To Patient 266 266
Low Oxygen Saturation 49 49
No Information 11 11
Insufficient Information 7 7
Bradycardia 7 7
No Code Available 5 5
Tachycardia 4 4
Aspiration/Inhalation 3 3
Cardiac Arrest 3 3
Burning Sensation 3 3
Hypoxia 3 3
Patient Problem/Medical Problem 2 2
Hypoventilation 2 2
Dizziness 2 2
Burn(s) 2 2
Increased Respiratory Rate 2 2
Headache 2 2
Death 1 1
Pneumothorax 1 1
Respiratory Distress 1 1
Respiratory Arrest 1 1
Fever 1 1
Needle Stick/Puncture 1 1
Exposure to Body Fluids 1 1
Dyspnea 1 1
Laceration(s) 1 1
Fluid Discharge 1 1
Pulmonary Edema 1 1
Unspecified Respiratory Problem 1 1
Extubate 1 1
Irritability 1 1
Unspecified Vascular Problem 1 1
Respiratory Failure 1 1
Full thickness (Third Degree) Burn 1 1
Increased Peak Expiratory Flow rate 1 1

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