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TPLC
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show TPLC since
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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
2
FISHER & PAYKEL HEALTHCARE LTD
SUBSTANTIALLY EQUIVALENT
4
FISHER & PAYKEL HEALTHCARE LTD.
SUBSTANTIALLY EQUIVALENT
1
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
TNI MEDICAL AG
SUBSTANTIALLY EQUIVALENT
1
VAPOTHERM INC.
SUBSTANTIALLY EQUIVALENT
1
1. K203357
HVT 2.0
VAPOTHERM, INC.
SUBSTANTIALLY EQUIVALENT
1
VINCENT HEALTHCARE PRODUCTS LIMITED
SUBSTANTIALLY EQUIVALENT
1
VYAIRE MEDICAL, INC.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2018
918
918
2019
894
894
2020
1188
1188
2021
1508
1508
2022
749
749
2023
641
641
Device Problems
MDRs with this Device Problem
Events in those MDRs
No Audible Alarm
3006
3006
Material Split, Cut or Torn
383
383
Leak/Splash
349
349
Crack
345
345
Break
328
328
Insufficient Heating
307
307
Fluid/Blood Leak
285
285
Failure to Power Up
186
186
Detachment of Device or Device Component
132
132
Device Alarm System
129
129
Complete Loss of Power
83
83
Gas/Air Leak
65
65
Melted
65
65
Defective Alarm
63
63
Power Problem
58
58
Adverse Event Without Identified Device or Use Problem
57
57
Mechanical Problem
55
55
Disconnection
52
52
Temperature Problem
50
50
Overfill
47
47
Therapeutic or Diagnostic Output Failure
32
32
Overheating of Device
30
30
Material Puncture/Hole
28
28
No Audible Prompt/Feedback
27
27
Defective Component
26
26
Use of Device Problem
26
26
Infusion or Flow Problem
24
24
Obstruction of Flow
23
23
Insufficient Information
22
22
Unexpected Shutdown
19
19
Improper Flow or Infusion
19
19
Defective Device
18
18
Device Displays Incorrect Message
18
18
Improper or Incorrect Procedure or Method
17
17
Stretched
17
17
Output Problem
16
16
No Apparent Adverse Event
16
16
No Flow
15
15
Protective Measures Problem
15
15
Misconnection
15
15
Moisture or Humidity Problem
14
14
Difficult to Open or Close
14
14
Loose or Intermittent Connection
13
13
Incorrect, Inadequate or Imprecise Result or Readings
13
13
Loss of Power
12
12
Fire
12
12
Contamination /Decontamination Problem
12
12
Connection Problem
12
12
Failure to Deliver
12
12
Device Emits Odor
11
11
Failure to Read Input Signal
11
11
Device Sensing Problem
10
10
Material Integrity Problem
10
10
Unintended Movement
10
10
Device Handling Problem
9
9
Intermittent Loss of Power
9
9
Failure of Device to Self-Test
9
9
Sparking
8
8
Noise, Audible
8
8
False Alarm
8
8
Filling Problem
7
7
Display or Visual Feedback Problem
7
7
Corroded
6
6
Degraded
6
6
Failure to Sense
6
6
Smoking
6
6
Component Missing
6
6
Inaudible or Unclear Audible Prompt/Feedback
6
6
Device Issue
5
5
Material Deformation
5
5
Electrical /Electronic Property Problem
5
5
Thermal Decomposition of Device
5
5
Excessive Heating
5
5
Material Separation
4
4
Failure to Select Signal
4
4
Device Slipped
4
4
Device Damaged Prior to Use
4
4
Ambient Temperature Problem
4
4
Human-Device Interface Problem
3
3
Device Operates Differently Than Expected
3
3
Material Twisted/Bent
3
3
Audible Prompt/Feedback Problem
3
3
Appropriate Term/Code Not Available
3
3
Physical Resistance/Sticking
3
3
No Device Output
3
3
Incorrect Measurement
3
3
Loss of or Failure to Bond
3
3
Complete Blockage
3
3
Air Leak
2
2
Burst Container or Vessel
2
2
Low Audible Alarm
2
2
No Display/Image
2
2
Unintended Ejection
2
2
Hole In Material
2
2
Product Quality Problem
2
2
Failure to Reset
2
2
Short Fill
2
2
Device Stops Intermittently
2
2
Fitting Problem
2
2
Device Fell
2
2
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
3019
3019
No Patient Involvement
1279
1279
No Known Impact Or Consequence To Patient
920
920
No Consequences Or Impact To Patient
319
319
Low Oxygen Saturation
209
209
Insufficient Information
87
87
Death
25
25
Burn(s)
14
14
No Information
14
14
Bradycardia
9
9
Hypoxia
8
8
Cardiac Arrest
7
7
Respiratory Distress
7
7
Partial thickness (Second Degree) Burn
7
7
Obstruction/Occlusion
6
6
Superficial (First Degree) Burn
5
5
Cough
4
4
Viral Infection
4
4
Tachycardia
4
4
Airway Obstruction
4
4
Dyspnea
4
4
Aspiration/Inhalation
3
3
Discomfort
3
3
Patient Problem/Medical Problem
3
3
Pneumonia
3
3
Respiratory Arrest
3
3
Unspecified Respiratory Problem
3
3
Increased Respiratory Rate
2
2
Burn, Thermal
2
2
No Code Available
2
2
Full thickness (Third Degree) Burn
2
2
Pressure Sores
2
2
Distress
1
1
Nasal Obstruction
1
1
Complaint, Ill-Defined
1
1
Inadequate Pain Relief
1
1
Ventilator Dependent
1
1
Virus
1
1
Chronic Obstructive Pulmonary Disease (COPD)
1
1
Skin Erosion
1
1
Swelling
1
1
Abrasion
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
Myocardial Infarction
1
1
Neurological Deficit/Dysfunction
1
1
Pain
1
1
Fibrosis
1
1
Cancer
1
1
Epistaxis
1
1
Electric Shock
1
1
Blood Loss
1
1
Respiratory Failure
1
1
Blister
1
1
Respiratory Insufficiency
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
4
Vyaire Medical
I
Jan-24-2018
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