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TPLC
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Device
humidifier, respiratory gas, (direct patient interface)
Product Code
BTT
Regulation Number
868.5450
Device Class
2
Premarket Reviews
Manufacturer
Decision
FISHER & PAYKEL HEALTHCARE
SUBSTANTIALLY EQUIVALENT
1
1. K201723
F&P Optiflow Nasal Oxygen Cannula with CO2 Samplin
...
FISHER & PAYKEL HEALTHCARE LTD
SUBSTANTIALLY EQUIVALENT
5
1. K201723
F&P Optiflow Nasal Oxygen Cannula with CO2 Samplin
...
FISHER & PAYKEL HEALTHCARE LTD.
SUBSTANTIALLY EQUIVALENT
1
1. K201723
F&P Optiflow Nasal Oxygen Cannula with CO2 Samplin
...
FISHER &PAYKEL HEALTHCARE LTD.
SUBSTANTIALLY EQUIVALENT
1
HOMETA INC
SUBSTANTIALLY EQUIVALENT
1
MEDLINE INDUSTRIES, INC.
SUBSTANTIALLY EQUIVALENT
1
PERMA PURE LLC
SUBSTANTIALLY EQUIVALENT
1
TELESAIR, INC.
SUBSTANTIALLY EQUIVALENT
1
VAPOTHERM INC.
SUBSTANTIALLY EQUIVALENT
1
VAPOTHERM, INC.
SUBSTANTIALLY EQUIVALENT
1
VINCENT HEALTHCARE PRODUCTS LIMITED
SUBSTANTIALLY EQUIVALENT
1
VYAIRE MEDICAL, INC.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2019
894
894
2020
1188
1188
2021
1508
1508
2022
749
749
2023
704
704
2024
117
117
Device Problems
MDRs with this Device Problem
Events in those MDRs
No Audible Alarm
2337
2337
Material Split, Cut or Torn
426
426
Leak/Splash
328
328
Break
327
327
Crack
315
315
Insufficient Heating
304
304
Fluid/Blood Leak
284
284
Failure to Power Up
184
184
Detachment of Device or Device Component
143
143
Device Alarm System
127
127
Complete Loss of Power
83
83
Gas/Air Leak
73
73
Defective Alarm
73
73
Melted
73
73
Mechanical Problem
60
60
Power Problem
57
57
Disconnection
52
52
Temperature Problem
48
48
Adverse Event Without Identified Device or Use Problem
48
48
Overfill
43
43
Therapeutic or Diagnostic Output Failure
32
32
Overheating of Device
28
28
Material Puncture/Hole
28
28
No Audible Prompt/Feedback
26
26
Use of Device Problem
25
25
Infusion or Flow Problem
24
24
Defective Component
23
23
Obstruction of Flow
22
22
Insufficient Information
22
22
Unexpected Shutdown
19
19
Stretched
19
19
Improper Flow or Infusion
18
18
Output Problem
16
16
Improper or Incorrect Procedure or Method
16
16
Misconnection
15
15
Protective Measures Problem
15
15
Defective Device
14
14
Difficult to Open or Close
14
14
Connection Problem
13
13
Device Displays Incorrect Message
13
13
No Flow
13
13
Incorrect, Inadequate or Imprecise Result or Readings
13
13
Loose or Intermittent Connection
13
13
Contamination /Decontamination Problem
12
12
Moisture or Humidity Problem
11
11
Unintended Movement
11
11
Device Emits Odor
11
11
Failure to Read Input Signal
11
11
Loss of Power
10
10
No Apparent Adverse Event
10
10
Intermittent Loss of Power
9
9
Material Integrity Problem
9
9
Failure of Device to Self-Test
9
9
Failure to Deliver
9
9
Fire
9
9
Sparking
8
8
Device Sensing Problem
7
7
Corroded
7
7
Display or Visual Feedback Problem
7
7
Filling Problem
6
6
Smoking
6
6
Failure to Sense
6
6
Excessive Heating
6
6
Noise, Audible
6
6
Material Deformation
5
5
Component Missing
5
5
Inaudible or Unclear Audible Prompt/Feedback
5
5
Failure to Select Signal
5
5
Fitting Problem
5
5
Electrical /Electronic Property Problem
5
5
Degraded
5
5
Thermal Decomposition of Device
5
5
Device Damaged Prior to Use
4
4
Ambient Temperature Problem
4
4
Material Twisted/Bent
3
3
Device Handling Problem
3
3
Physical Resistance/Sticking
3
3
Audible Prompt/Feedback Problem
3
3
Device Slipped
3
3
Material Separation
3
3
Complete Blockage
3
3
False Alarm
3
3
Loss of or Failure to Bond
3
3
Incorrect Measurement
3
3
Inaccurate Flow Rate
2
2
No Display/Image
2
2
Partial Blockage
2
2
Low Audible Alarm
2
2
Burst Container or Vessel
2
2
Product Quality Problem
2
2
Inappropriate Audible Prompt/Feedback
2
2
Tear, Rip or Hole in Device Packaging
2
2
Device Fell
2
2
Incomplete or Inadequate Connection
2
2
Patient Device Interaction Problem
2
2
Material Too Soft/Flexible
2
2
Scratched Material
2
2
Appropriate Term/Code Not Available
2
2
Material Protrusion/Extrusion
2
2
Flare or Flash
2
2
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
3175
3175
No Patient Involvement
801
801
No Known Impact Or Consequence To Patient
657
657
Low Oxygen Saturation
207
207
No Consequences Or Impact To Patient
176
176
Insufficient Information
90
90
Death
19
19
Burn(s)
13
13
No Information
12
12
Bradycardia
9
9
Cardiac Arrest
8
8
Hypoxia
7
7
Respiratory Distress
5
5
Obstruction/Occlusion
5
5
Superficial (First Degree) Burn
5
5
Partial thickness (Second Degree) Burn
5
5
Cough
4
4
Unspecified Respiratory Problem
4
4
Viral Infection
4
4
Pneumonia
4
4
Tachycardia
4
4
Dyspnea
4
4
Airway Obstruction
4
4
Aspiration/Inhalation
3
3
Discomfort
3
3
Cancer
3
3
Respiratory Arrest
3
3
Patient Problem/Medical Problem
3
3
Full thickness (Third Degree) Burn
3
3
Increased Respiratory Rate
2
2
Burn, Thermal
2
2
No Code Available
2
2
Pressure Sores
2
2
Nasal Obstruction
1
1
Complaint, Ill-Defined
1
1
Inadequate Pain Relief
1
1
Ventilator Dependent
1
1
Virus
1
1
Burning Sensation
1
1
Chronic Obstructive Pulmonary Disease (COPD)
1
1
Swelling
1
1
Asthma
1
1
Bacterial Infection
1
1
Arrhythmia
1
1
Stroke/CVA
1
1
Cyanosis
1
1
Erythema
1
1
Fever
1
1
Hyperventilation
1
1
Low Blood Pressure/ Hypotension
1
1
Hypothermia
1
1
Unspecified Infection
1
1
Inflammation
1
1
Neurological Deficit/Dysfunction
1
1
Pain
1
1
Respiratory Insufficiency
1
1
Epistaxis
1
1
Respiratory Failure
1
1
Decreased Respiratory Rate
1
1
Fibrosis
1
1
Blister
1
1
Skin Inflammation/ Irritation
1
1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Hamilton Medical AG
III
Jul-14-2022
2
TELEFLEX MEDICAL INC
I
Feb-07-2020
3
Vapotherm
II
Mar-17-2023
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