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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
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
PERMA PURE LLC
SUBSTANTIALLY EQUIVALENT
1
TNI MEDICAL AG
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
2018
918
918
2019
894
894
2020
1188
1188
2021
1508
1508
2022
749
749
2023
494
494
Device Problems
MDRs with this Device Problem
Events in those MDRs
No Audible Alarm
2962
2962
Material Split, Cut or Torn
365
365
Leak/Splash
343
343
Break
328
328
Crack
326
326
Insufficient Heating
306
306
Fluid/Blood Leak
272
272
Failure to Power Up
186
186
Device Alarm System
129
129
Detachment of Device or Device Component
125
125
Complete Loss of Power
83
83
Melted
64
64
Gas/Air Leak
63
63
Power Problem
58
58
Adverse Event Without Identified Device or Use Problem
56
56
Defective Alarm
55
55
Mechanical Problem
52
52
Disconnection
51
51
Overfill
46
46
Temperature Problem
45
45
Therapeutic or Diagnostic Output Failure
32
32
Overheating of Device
30
30
Material Puncture/Hole
28
28
Use of Device Problem
27
27
No Audible Prompt/Feedback
27
27
Defective Component
25
25
Infusion or Flow Problem
24
24
Insufficient Information
20
20
Obstruction of Flow
20
20
Improper Flow or Infusion
19
19
Defective Device
18
18
Device Displays Incorrect Message
18
18
Unexpected Shutdown
18
18
Improper or Incorrect Procedure or Method
17
17
Misconnection
16
16
Output Problem
16
16
No Apparent Adverse Event
16
16
No Flow
15
15
Protective Measures Problem
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
Connection Problem
12
12
Failure to Deliver
12
12
Device Emits Odor
11
11
Failure to Read Input Signal
11
11
Stretched
11
11
Fire
11
11
Device Sensing Problem
10
10
Unintended Movement
10
10
Intermittent Loss of Power
9
9
Device Handling Problem
9
9
Material Integrity Problem
9
9
Failure of Device to Self-Test
9
9
Noise, Audible
8
8
False Alarm
8
8
Filling Problem
7
7
Display or Visual Feedback Problem
7
7
Degraded
6
6
Smoking
6
6
Failure to Sense
6
6
Contamination /Decontamination Problem
6
6
Inaudible or Unclear Audible Prompt/Feedback
6
6
Sparking
6
6
Component Missing
5
5
Device Issue
5
5
Material Deformation
5
5
Electrical /Electronic Property Problem
5
5
Corroded
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
Device Operates Differently Than Expected
3
3
Human-Device Interface Problem
3
3
Material Twisted/Bent
3
3
Physical Resistance/Sticking
3
3
Appropriate Term/Code Not Available
3
3
No Device Output
3
3
Incorrect Measurement
3
3
Loss of or Failure to Bond
3
3
Complete Blockage
3
3
Audible Prompt/Feedback Problem
3
3
Incomplete or Inadequate Connection
2
2
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
Failure to Reset
2
2
Device Stops Intermittently
2
2
Fitting Problem
2
2
Device Fell
2
2
Patient Device Interaction Problem
2
2
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
2882
2882
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
203
203
Insufficient Information
85
85
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
Viral Infection
4
4
Airway Obstruction
4
4
Dyspnea
4
4
Superficial (First Degree) Burn
4
4
Cough
4
4
Respiratory Arrest
3
3
Patient Problem/Medical Problem
3
3
Pneumonia
3
3
Aspiration/Inhalation
3
3
Discomfort
3
3
Tachycardia
3
3
Pressure Sores
2
2
Unspecified Respiratory Problem
2
2
No Code Available
2
2
Full thickness (Third Degree) Burn
2
2
Increased Respiratory Rate
2
2
Burn, Thermal
2
2
Electric Shock
1
1
Blood Loss
1
1
Fibrosis
1
1
Cancer
1
1
Respiratory Insufficiency
1
1
Epistaxis
1
1
Blister
1
1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
1
1
Distress
1
1
Complaint, Ill-Defined
1
1
Ventilator Dependent
1
1
Nasal Obstruction
1
1
Respiratory Failure
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
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
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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