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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
VAPOTHERM, INC.
  GRANTED 1

MDR Year MDR Reports MDR Events
2020 1 1
2021 1 1
2022 6 6

Device Problems MDRs with this Device Problem Events in those MDRs
Protective Measures Problem 2 2
Obstruction of Flow 2 2
No Apparent Adverse Event 2 2
Improper Flow or Infusion 1 1
Output Problem 1 1
No Audible Alarm 1 1
No Display/Image 1 1
Failure to Deliver 1 1
Defective Alarm 1 1
Insufficient Flow or Under Infusion 1 1
Output below Specifications 1 1
Material Twisted/Bent 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Hypoxia 4 4
Low Oxygen Saturation 3 3
Dyspnea 1 1
Loss of consciousness 1 1
Diminished Pulse Pressure 1 1
Respiratory Arrest 1 1
No Clinical Signs, Symptoms or Conditions 1 1
Cardiac Arrest 1 1

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