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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 125 125
2024 177 177
2025 75 75

Device Problems MDRs with this Device Problem Events in those MDRs
Leak/Splash 294 294
Gas/Air Leak 242 242
Crack 92 92
Break 52 52
Material Split, Cut or Torn 41 41
Therapeutic or Diagnostic Output Failure 40 40
Insufficient Heating 30 30
Fluid/Blood Leak 29 29
Disconnection 28 28
Failure of Device to Self-Test 28 28
Connection Problem 18 18
Loose or Intermittent Connection 13 13
Incorrect, Inadequate or Imprecise Result or Readings 12 12
Degraded 11 11
Mechanical Problem 10 10
Material Puncture/Hole 10 10
Detachment of Device or Device Component 9 9
Melted 6 6
Use of Device Problem 6 6
Misconnection 5 5
Fracture 5 5
Component Missing 5 5
Manufacturing, Packaging or Shipping Problem 5 5
Moisture or Humidity Problem 5 5
Material Deformation 4 4
Infusion or Flow Problem 4 4
Failure to Disconnect 3 3
Corroded 3 3
Misassembly by Users 3 3
Improper or Incorrect Procedure or Method 3 3
Output Problem 3 3
Fitting Problem 3 3
Material Perforation 3 3
Misassembled 3 3
Appropriate Term/Code Not Available 2 2
Misassembled During Installation 2 2
Insufficient Information 2 2
Protective Measures Problem 2 2
Material Twisted/Bent 2 2
Fire 2 2
Overfill 2 2
Obstruction of Flow 2 2
Ambient Temperature Problem 2 2
Inadequacy of Device Shape and/or Size 1 1
Installation-Related Problem 1 1
Device Slipped 1 1
Device Damaged Prior to Use 1 1
Contamination /Decontamination Problem 1 1
Deformation Due to Compressive Stress 1 1
Device Displays Incorrect Message 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 651 651
No Patient Involvement 50 50
No Known Impact Or Consequence To Patient 28 28
Low Oxygen Saturation 22 22
No Consequences Or Impact To Patient 11 11
Insufficient Information 10 10
Aspiration/Inhalation 3 3
Hypoxia 3 3
Burning Sensation 3 3
Bradycardia 2 2
Headache 2 2
Pneumothorax 2 2
Dizziness 2 2
Irritability 1 1
Increased Peak Expiratory Flow rate 1 1
Respiratory Failure 1 1
Increased Respiratory Rate 1 1
Abnormal Blood Gases 1 1
Death 1 1
Dyspnea 1 1
Hypoventilation 1 1
Unspecified Vascular Problem 1 1
Respiratory Arrest 1 1
Unspecified Respiratory Problem 1 1
Laceration(s) 1 1
Tachycardia 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Vyaire Medical I May-09-2025
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