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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
EXCELERON MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
  1.  K241268  Thermalite Heated CPAP Tube (CTUBH06H15DS-2, CTUBH ...
MEDLINE INDUSTRIES, LP
  SUBSTANTIALLY EQUIVALENT 1
SUNSET HEALTHCARE SOLUTIONS, INC.
  SUBSTANTIALLY EQUIVALENT 1
TELEFLEX MEDICAL, INC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2018 103 103
2019 134 134
2020 123 123
2021 124 124
2022 152 152
2023 125 125
2024 121 121

Device Problems MDRs with this Device Problem Events in those MDRs
Leak/Splash 312 312
Gas/Air Leak 184 184
Crack 105 105
Insufficient Heating 72 72
Disconnection 65 65
Break 56 56
Therapeutic or Diagnostic Output Failure 42 42
Material Split, Cut or Torn 41 41
Failure of Device to Self-Test 29 29
Connection Problem 25 25
Fluid/Blood Leak 20 20
Incorrect, Inadequate or Imprecise Result or Readings 19 19
Loose or Intermittent Connection 17 17
Material Puncture/Hole 15 15
Detachment of Device or Device Component 15 15
Temperature Problem 14 14
Degraded 13 13
Moisture or Humidity Problem 11 11
Melted 11 11
Use of Device Problem 10 10
No Apparent Adverse Event 8 8
Material Separation 7 7
Device Handling Problem 6 6
Mechanical Problem 6 6
Ambient Temperature Problem 6 6
Manufacturing, Packaging or Shipping Problem 6 6
Misconnection 5 5
Material Deformation 5 5
Material Perforation 5 5
Component Missing 5 5
Infusion or Flow Problem 4 4
Fracture 4 4
Output Problem 4 4
Device Displays Incorrect Message 4 4
Device Fell 3 3
Insufficient Information 3 3
Obstruction of Flow 3 3
Corroded 3 3
Improper or Incorrect Procedure or Method 3 3
Fire 3 3
Thermal Decomposition of Device 3 3
Failure to Disconnect 3 3
Misassembled 3 3
Fitting Problem 3 3
Adverse Event Without Identified Device or Use Problem 3 3
Protective Measures Problem 2 2
Appropriate Term/Code Not Available 2 2
Overheating of Device 2 2
Device Issue 2 2
Detachment Of Device Component 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 528 528
No Patient Involvement 146 146
No Known Impact Or Consequence To Patient 96 96
No Consequences Or Impact To Patient 77 77
Low Oxygen Saturation 27 27
Insufficient Information 8 8
Bradycardia 4 4
Aspiration/Inhalation 3 3
Burning Sensation 3 3
Hypoxia 3 3
Hypoventilation 2 2
Dizziness 2 2
Burn(s) 2 2
Headache 2 2
Death 1 1
Pneumothorax 1 1
No Code Available 1 1
Respiratory Arrest 1 1
Cardiac Arrest 1 1
Dyspnea 1 1
Laceration(s) 1 1
Tachycardia 1 1
Increased Respiratory Rate 1 1
Unspecified Respiratory Problem 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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