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Device
humidifier, respiratory gas, (direct patient interface)
Regulation Description
Respiratory gas humidifier.
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
8
FISHER & PAYKEL HEALTHCARE LTD.
SUBSTANTIALLY EQUIVALENT
1
FISHER &PAYKEL HEALTHCARE LTD.
SUBSTANTIALLY EQUIVALENT
1
HOMETA INC
SUBSTANTIALLY EQUIVALENT
1
INVENT MEDICAL CORPORATION
SUBSTANTIALLY EQUIVALENT
1
LABORATORIOS BIOGALENIC, S.A. DE C.V.
SUBSTANTIALLY EQUIVALENT
1
MEDLINE INDUSTRIES, INC.
SUBSTANTIALLY EQUIVALENT
1
MEDLINE INDUSTRIES, LP.
SUBSTANTIALLY EQUIVALENT
3
PERMA PURE LLC
SUBSTANTIALLY EQUIVALENT
1
TELESAIR, 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
2020
1188
1188
2021
1508
1508
2022
749
749
2023
717
717
2024
501
501
2025
294
294
Device Problems
MDRs with this Device Problem
Events in those MDRs
No Audible Alarm
1803
1803
Material Split, Cut or Torn
533
533
Leak/Splash
355
355
Break
355
355
Crack
314
314
Insufficient Heating
300
300
Fluid/Blood Leak
292
292
Detachment of Device or Device Component
267
267
Failure to Power Up
181
181
Gas/Air Leak
104
104
Device Alarm System
103
103
Melted
87
87
Complete Loss of Power
83
83
Defective Alarm
81
81
Mechanical Problem
79
79
Power Problem
57
57
Disconnection
51
51
Temperature Problem
48
48
Adverse Event Without Identified Device or Use Problem
42
42
Stretched
35
35
Overfill
34
34
Insufficient Information
31
31
Material Puncture/Hole
31
31
Therapeutic or Diagnostic Output Failure
28
28
No Audible Prompt/Feedback
24
24
Overheating of Device
24
24
Device Dislodged or Dislocated
23
23
Infusion or Flow Problem
21
21
Unexpected Shutdown
18
18
Improper Flow or Infusion
17
17
Obstruction of Flow
17
17
Use of Device Problem
17
17
Output Problem
16
16
Connection Problem
15
15
Misconnection
14
14
Moisture or Humidity Problem
14
14
Protective Measures Problem
14
14
Defective Device
13
13
Contamination /Decontamination Problem
12
12
Failure to Read Input Signal
11
11
Unintended Movement
11
11
Difficult to Open or Close
11
11
Improper or Incorrect Procedure or Method
11
11
No Flow
11
11
Device Emits Odor
10
10
Loose or Intermittent Connection
10
10
Sparking
10
10
Material Integrity Problem
10
10
Intermittent Loss of Power
9
9
Fire
9
9
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
3789
3789
No Patient Involvement
350
350
No Known Impact Or Consequence To Patient
314
314
Low Oxygen Saturation
251
251
Insufficient Information
106
106
No Consequences Or Impact To Patient
87
87
Burn(s)
14
14
Death
12
12
Hypoxia
12
12
No Information
12
12
Cardiac Arrest
9
9
Bradycardia
8
8
Partial thickness (Second Degree) Burn
8
8
Superficial (First Degree) Burn
6
6
Unspecified Respiratory Problem
6
6
Obstruction/Occlusion
5
5
Cancer
5
5
Cough
4
4
Pneumonia
4
4
Airway Obstruction
4
4
Viral Infection
4
4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
3
3
Tachycardia
3
3
Respiratory Arrest
3
3
Respiratory Failure
3
3
Dyspnea
3
3
Discomfort
3
3
Increased Respiratory Rate
2
2
Pain
2
2
Pressure Sores
2
2
Blister
2
2
Burn, Thermal
2
2
Respiratory Distress
2
2
Full thickness (Third Degree) Burn
2
2
Bacterial Infection
1
1
Inadequate Pain Relief
1
1
Irritability
1
1
Hyperventilation
1
1
Fibrosis
1
1
Respiratory Insufficiency
1
1
Low Blood Pressure/ Hypotension
1
1
Ventilator Dependent
1
1
Decreased Respiratory Rate
1
1
Distress
1
1
Heart Failure/Congestive Heart Failure
1
1
Nasal Obstruction
1
1
Unspecified Kidney or Urinary Problem
1
1
Hypothermia
1
1
Respiratory Tract Infection
1
1
Swelling
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
Vapotherm
II
Mar-17-2023
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