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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
CARDINAL HEALTH, INC.
SUBSTANTIALLY EQUIVALENT
1
CAREFUSION 2200, INC.
SUBSTANTIALLY EQUIVALENT
1
DRAEGER MEDICAL AG & CO. KG
SUBSTANTIALLY EQUIVALENT
1
FISHER & PAYKEL HEALTHCARE
SUBSTANTIALLY EQUIVALENT
3
FISHER & PAYKEL HEALTHCARE LTD
SUBSTANTIALLY EQUIVALENT
6
FISHER & PAYKEL HEALTHCARE LTD.
SUBSTANTIALLY EQUIVALENT
1
FISHER & PAYKEL HEALTHCARE, LTD.
SUBSTANTIALLY EQUIVALENT
7
FISHER &PAYKEL HEALTHCARE LTD.
SUBSTANTIALLY EQUIVALENT
1
FLEXICARE MEDICAL LIMITED
SUBSTANTIALLY EQUIVALENT
1
GRUENDLER GMBH
SUBSTANTIALLY EQUIVALENT
1
GRUNDLER GMBH
SUBSTANTIALLY EQUIVALENT
1
HAMILTON MEDICAL AG
SUBSTANTIALLY EQUIVALENT
2
HOMETA INC
SUBSTANTIALLY EQUIVALENT
1
MEDISIZE BV
SUBSTANTIALLY EQUIVALENT
1
MEDLINE INDUSTRIES, INC.
SUBSTANTIALLY EQUIVALENT
1
PACIFIC MEDICO CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
PERMA PURE LLC
SUBSTANTIALLY EQUIVALENT
1
1. K193411
O2asis Personal Oxygen Humidifier
SALTER LABS
SUBSTANTIALLY EQUIVALENT
1
SALTER LABS, ARVIN FACILITY
SUBSTANTIALLY EQUIVALENT
1
SMITHS MEDICAL ASD, INC.
SUBSTANTIALLY EQUIVALENT
1
SOMNETICS INTERNATIONAL, INC.
SUBSTANTIALLY EQUIVALENT
1
TELEFLEX MEDICAL , INC.
SUBSTANTIALLY EQUIVALENT
1
TELEFLEX MEDICAL, INC
SUBSTANTIALLY EQUIVALENT
1
TELEFLEX, INC.
SUBSTANTIALLY EQUIVALENT
3
TELESAIR, INC.
SUBSTANTIALLY EQUIVALENT
1
TNI MEDICAL AG
SUBSTANTIALLY EQUIVALENT
1
VAPOTHERM INC.
SUBSTANTIALLY EQUIVALENT
1
VAPOTHERM, INC.
SUBSTANTIALLY EQUIVALENT
3
VENTLAB CORP.
SUBSTANTIALLY EQUIVALENT
1
VINCENT HEALTHCARE PRODUCTS LIMITED
SUBSTANTIALLY EQUIVALENT
1
VYAIRE MEDICAL, INC.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2014
716
716
2015
669
669
2016
1094
1094
2017
1007
1007
2018
918
918
2019
894
894
2020
1188
1188
2021
1508
1508
2022
749
749
2023
704
704
2024
199
199
Device Problems
MDRs with this Device Problem
Events in those MDRs
No Audible Alarm
4364
4364
Leak/Splash
625
625
Crack
531
531
Break
455
455
Material Split, Cut or Torn
438
438
Fluid/Blood Leak
418
418
Insufficient Heating
399
399
Failure to Power Up
376
376
Power Problem
287
287
Device Alarm System
247
247
Device Operates Differently Than Expected
217
217
Connection Problem
205
205
Temperature Problem
187
187
Detachment of Device or Device Component
157
157
Melted
111
111
Overheating of Device
93
93
Defective Alarm
92
92
Complete Loss of Power
83
83
Disconnection
78
78
Gas/Air Leak
76
76
Adverse Event Without Identified Device or Use Problem
72
72
Mechanical Problem
63
63
Device Displays Incorrect Message
57
57
Overfill
54
54
Device Issue
46
46
Insufficient Information
37
37
Moisture or Humidity Problem
35
35
No Flow
35
35
Therapeutic or Diagnostic Output Failure
33
33
Use of Device Problem
33
33
Hole In Material
32
32
Failure of Device to Self-Test
31
31
Device Handling Problem
29
29
Material Puncture/Hole
29
29
Defective Component
28
28
Device Sensing Problem
28
28
Infusion or Flow Problem
28
28
No Audible Prompt/Feedback
27
27
Obstruction of Flow
26
26
Protective Measures Problem
26
26
Improper or Incorrect Procedure or Method
25
25
Device Stops Intermittently
24
24
Improper Flow or Infusion
24
24
Air Leak
23
23
No Display/Image
22
22
Fitting Problem
22
22
Stretched
20
20
Loss of Power
20
20
Defective Device
20
20
Detachment Of Device Component
20
20
Misconnection
19
19
Loose or Intermittent Connection
19
19
Device Emits Odor
19
19
Failure to Deliver
19
19
Unexpected Shutdown
19
19
Difficult to Open or Close
18
18
False Alarm
18
18
Output Problem
17
17
No Apparent Adverse Event
16
16
Noise, Audible
15
15
Fire
15
15
Filling Problem
14
14
Failure to Sense
14
14
Smoking
14
14
Appropriate Term/Code Not Available
14
14
Unintended Movement
13
13
Incorrect, Inadequate or Imprecise Result or Readings
13
13
Contamination /Decontamination Problem
12
12
Pressure Problem
12
12
Material Integrity Problem
11
11
Failure to Read Input Signal
11
11
Kinked
11
11
Loss of or Failure to Bond
10
10
Display or Visual Feedback Problem
10
10
Cut In Material
10
10
Material Deformation
10
10
Intermittent Loss of Power
9
9
Sparking
9
9
Material Separation
9
9
Device Inoperable
9
9
Corroded
9
9
Thermal Decomposition of Device
9
9
Burst Container or Vessel
9
9
Partial Blockage
8
8
Restricted Flow rate
8
8
Moisture Damage
8
8
Device Damaged Prior to Use
8
8
Tear, Rip or Hole in Device Packaging
8
8
Component Missing
8
8
Electrical /Electronic Property Problem
7
7
Degraded
6
6
Circuit Failure
6
6
No Device Output
6
6
Device Slipped
6
6
Inaudible or Unclear Audible Prompt/Feedback
6
6
Torn Material
6
6
Excessive Heating
6
6
Device Contamination with Chemical or Other Material
6
6
Failure to Select Signal
5
5
Split
5
5
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
3245
3245
No Patient Involvement
2943
2943
No Known Impact Or Consequence To Patient
1749
1749
No Consequences Or Impact To Patient
1317
1318
Low Oxygen Saturation
270
270
No Information
118
118
Insufficient Information
94
94
Death
38
38
Burn(s)
27
27
Respiratory Distress
14
14
Hypoxia
13
13
No Code Available
13
13
Bradycardia
11
11
Partial thickness (Second Degree) Burn
11
11
Cardiac Arrest
10
10
Dyspnea
9
9
Obstruction/Occlusion
8
8
Aspiration/Inhalation
7
7
Superficial (First Degree) Burn
7
7
Pneumonia
6
6
Discomfort
6
6
Burn, Thermal
5
5
Patient Problem/Medical Problem
5
5
Cancer
5
5
Cough
4
4
Unspecified Respiratory Problem
4
4
Viral Infection
4
4
Tachycardia
4
4
Airway Obstruction
4
4
Erythema
3
3
Complaint, Ill-Defined
3
3
Full thickness (Third Degree) Burn
3
3
Respiratory Arrest
3
3
Decreased Respiratory Rate
2
2
Increased Respiratory Rate
2
2
Injury
2
2
Pressure Sores
2
2
Distress
2
2
Ventilator Dependent
2
2
Pneumothorax
2
2
Cyanosis
2
2
Unspecified Infection
2
2
Inflammation
1
1
Myocardial Infarction
1
1
Neurological Deficit/Dysfunction
1
1
Pain
1
1
Asthma
1
1
Bacterial Infection
1
1
Skin Erosion
1
1
Swelling
1
1
Virus
1
1
Burning Sensation
1
1
Chronic Obstructive Pulmonary Disease (COPD)
1
1
Fever
1
1
Hemorrhage/Bleeding
1
1
Hyperventilation
1
1
Low Blood Pressure/ Hypotension
1
1
Hypothermia
1
1
Hypoventilation
1
1
Hypovolemic Shock
1
1
Arrhythmia
1
1
Abnormal Blood Gases
1
1
Abrasion
1
1
Adult Respiratory Distress Syndrome
1
1
Stroke/CVA
1
1
Chest Pain
1
1
Resuscitation
1
1
Respiratory Tract Infection
1
1
Irritability
1
1
Chest Tightness/Pressure
1
1
Nasal Obstruction
1
1
Respiratory Failure
1
1
Therapeutic Response, Decreased
1
1
Inadequate Pain Relief
1
1
Inadequate Osseointegration
1
1
Fibrosis
1
1
Underdose
1
1
Confusion/ Disorientation
1
1
Electric Shock
1
1
Missed Dose
1
1
Chemical Exposure
1
1
Blood Loss
1
1
Vitrectomy
1
1
Respiratory Insufficiency
1
1
Epistaxis
1
1
Multiple Organ Failure
1
1
Unspecified Kidney or Urinary Problem
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
Fisher & Paykel Healthcare, Ltd.
II
May-15-2024
2
Hamilton Medical AG
III
Jul-14-2022
3
TELEFLEX MEDICAL INC
I
Feb-07-2020
4
Telefelx Medical
II
Mar-09-2010
5
Teleflex Medical
II
Dec-15-2015
6
Teleflex Medical
II
Apr-30-2015
7
Teleflex Medical
II
Feb-12-2015
8
Teleflex Medical
II
Jul-23-2014
9
Teleflex Medical
II
Jul-07-2014
10
Teleflex Medical
II
Jul-19-2012
11
Teleflex Medical
II
Jul-12-2011
12
Teleflex Medical
I
Aug-13-2010
13
Vapotherm
II
Mar-17-2023
14
Vapotherm, Inc.
II
Sep-25-2014
15
Vyaire Medical
I
Jan-24-2018
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