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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
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
2020 1 1
2021 1 1
2022 6 6
2023 3 3
2024 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Obstruction of Flow 2 2
Output Problem 2 2
Protective Measures Problem 2 2
No Apparent Adverse Event 2 2
Improper Flow or Infusion 1 1
Material Twisted/Bent 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Output below Specifications 1 1
Device Alarm System 1 1
Defective Alarm 1 1
No Audible Alarm 1 1
No Display/Image 1 1
Insufficient Flow or Under Infusion 1 1
Failure to Deliver 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Low Oxygen Saturation 6 6
Hypoxia 4 4
Dyspnea 2 2
Cardiac Arrest 1 1
Pneumothorax 1 1
Dizziness 1 1
Loss of consciousness 1 1
Respiratory Failure 1 1
Diminished Pulse Pressure 1 1
Respiratory Arrest 1 1
Insufficient Information 1 1
No Clinical Signs, Symptoms or Conditions 1 1

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