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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
Regulation Description Breathing system heater.
Product CodeBZE
Regulation Number 868.5270
Device Class 2


Premarket Reviews
ManufacturerDecision
DRAEGERWERK AG & CO. KGAA
  SUBSTANTIALLY EQUIVALENT 1
EXCELERON MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
MEDLINE INDUSTRIES, LP
  SUBSTANTIALLY EQUIVALENT 1
SUNSET HEALTHCARE SOLUTIONS, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 123 123
2021 124 124
2022 152 152
2023 124 124
2024 177 177
2025 11 11

Device Problems MDRs with this Device Problem Events in those MDRs
Leak/Splash 281 281
Gas/Air Leak 205 205
Crack 83 83
Break 52 52
Material Split, Cut or Torn 40 40
Therapeutic or Diagnostic Output Failure 40 40
Insufficient Heating 30 30
Failure of Device to Self-Test 28 28
Disconnection 28 28
Fluid/Blood Leak 27 27
Connection Problem 14 14
Incorrect, Inadequate or Imprecise Result or Readings 12 12
Loose or Intermittent Connection 12 12
Degraded 11 11
Material Puncture/Hole 10 10
Detachment of Device or Device Component 9 9
Mechanical Problem 9 9
Use of Device Problem 6 6
Misconnection 5 5
Manufacturing, Packaging or Shipping Problem 5 5
Component Missing 5 5
Infusion or Flow Problem 4 4
Moisture or Humidity Problem 4 4
Material Deformation 4 4
Melted 4 4
Fracture 3 3
Misassembled 3 3
Improper or Incorrect Procedure or Method 3 3
Output Problem 3 3
Fitting Problem 3 3
Failure to Disconnect 3 3
Corroded 3 3
Overfill 2 2
Fire 2 2
Appropriate Term/Code Not Available 2 2
Ambient Temperature Problem 2 2
Material Perforation 2 2
Material Twisted/Bent 2 2
Obstruction of Flow 2 2
Misassembled During Installation 2 2
Insufficient Information 2 2
Misassembly by Users 2 2
Protective Measures Problem 2 2
Contamination /Decontamination Problem 1 1
Decrease in Pressure 1 1
Noise, Audible 1 1
Complete Blockage 1 1
Thermal Decomposition of Device 1 1
Material Discolored 1 1
Deformation Due to Compressive Stress 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 589 589
No Patient Involvement 50 50
No Known Impact Or Consequence To Patient 28 28
Low Oxygen Saturation 20 20
No Consequences Or Impact To Patient 11 11
Insufficient Information 9 9
Hypoxia 3 3
Burning Sensation 3 3
Aspiration/Inhalation 3 3
Dizziness 2 2
Bradycardia 2 2
Headache 2 2
Respiratory Failure 1 1
Unspecified Vascular Problem 1 1
Irritability 1 1
Laceration(s) 1 1
Dyspnea 1 1
Unspecified Respiratory Problem 1 1
Abnormal Blood Gases 1 1
Pneumothorax 1 1
Hypoventilation 1 1
Tachycardia 1 1
Increased Peak Expiratory Flow rate 1 1
Respiratory Arrest 1 1
Increased Respiratory Rate 1 1
Death 1 1

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