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TPLC
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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 Code
QAV
Regulation Number
868.5454
Device Class
2
Premarket Reviews
Manufacturer
Decision
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
2023
3
3
2024
5
5
Device Problems
MDRs with this Device Problem
Events in those MDRs
Output Problem
2
2
No Apparent Adverse Event
2
2
Obstruction of Flow
2
2
Protective Measures Problem
2
2
No Display/Image
1
1
Device Alarm System
1
1
Failure to Deliver
1
1
No Audible Alarm
1
1
Material Twisted/Bent
1
1
Improper Flow or Infusion
1
1
Insufficient Flow or Under Infusion
1
1
Adverse Event Without Identified Device or Use Problem
1
1
Defective Alarm
1
1
Improper or Incorrect Procedure or Method
1
1
Output below Specifications
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Low Oxygen Saturation
6
6
Hypoxia
4
4
Pneumothorax
2
2
No Clinical Signs, Symptoms or Conditions
2
2
Dyspnea
2
2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
1
1
Respiratory Arrest
1
1
Dizziness
1
1
Diminished Pulse Pressure
1
1
Pulmonary Emphysema
1
1
Cardiac Arrest
1
1
Insufficient Information
1
1
Loss of consciousness
1
1
Respiratory Failure
1
1
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