TPLC - Total Product Life Cycle

• 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 Code: QAV
• Regulation Number: 868.5454
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
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	7	7
2025	10	10
2026	11	11

Device Problems	MDRs with this Device Problem	Events in those MDRs
No Audible Alarm	13	13
Insufficient Device Problem Information	3	3
Adverse Event Without Identified Device or Use Problem	3	3
Break	2	2
No Apparent Adverse Event	2	2
Sparking	1	1
Device Alarm System	1	1
Degraded	1	1
Obstruction of Flow	1	1
Improper or Incorrect Procedure or Method	1	1
Fluid/Blood Leak	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	19	19
Low Oxygen Saturation	8	8
Insufficient Information	5	5
Hypoxia	4	4
Pneumothorax	2	2
Dyspnea	2	2
Apnea	1	1
Respiratory Arrest	1	1
Dizziness	1	1
Pulmonary Emphysema	1	1
Diminished Pulse Pressure	1	1
Cardiac Arrest	1	1
Pressure Sore/Ulcer	1	1
Skin Tears	1	1
Loss of consciousness	1	1
Respiratory Failure	1	1
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	1	1

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