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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device high flow/high velocity humidified oxygen delivery device
Regulation Description High flow humidified oxygen delivery device.
Definition Intended to deliver high flow and/or high velocity oxygen with humidification.
Product CodeQAV
Regulation Number 868.5454
Device Class 2


Premarket Reviews
ManufacturerDecision
FISHER & PAYKEL HEALTHCARE
  SUBSTANTIALLY EQUIVALENT 1
VAPOTHERM, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2021 1 1
2022 6 6
2023 3 3
2024 7 7
2025 10 10
2026 10 10

Device Problems MDRs with this Device Problem Events in those MDRs
No Audible Alarm 13 13
Insufficient Information 3 3
Adverse Event Without Identified Device or Use Problem 3 3
Break 2 2
Obstruction of Flow 2 2
No Apparent Adverse Event 2 2
Protective Measures Problem 2 2
Sparking 1 1
No Display/Image 1 1
Output Problem 1 1
Device Alarm System 1 1
Wrong Label 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
Failure to Deliver 1 1
Degraded 1 1
Unable to Obtain Readings 1 1
Improper Flow or Infusion 1 1
Material Twisted/Bent 1 1
Defective Alarm 1 1
Application Program Freezes, Becomes Nonfunctional 1 1
Improper or Incorrect Procedure or Method 1 1
No Flow 1 1
Fluid/Blood Leak 1 1
Output below Specifications 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 17 17
Low Oxygen Saturation 6 6
Insufficient Information 5 5
Hypoxia 4 4
Pneumothorax 2 2
Dyspnea 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Apnea 1 1
Respiratory Arrest 1 1
Dizziness 1 1
Pulmonary Emphysema 1 1
Diminished Pulse Pressure 1 1
Cardiac Arrest 1 1
Skin Tears 1 1
Pressure Sores 1 1
Loss of consciousness 1 1
Respiratory Failure 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Fisher & Paykel Healthcare, Ltd. II Sep-25-2024
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