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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
FISHER & PAYKEL HEALTHCARE LTD
SUBSTANTIALLY EQUIVALENT
2
FISHER & PAYKEL HEALTHCARE LTD.
SUBSTANTIALLY EQUIVALENT
1
FISHER &PAYKEL HEALTHCARE LTD.
SUBSTANTIALLY EQUIVALENT
1
PERMA PURE LLC
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
MDR Year
MDR Reports
MDR Events
2018
918
918
2019
894
894
2020
1188
1188
2021
1508
1508
2022
751
751
2023
100
100
Device Problems
MDRs with this Device Problem
Events in those MDRs
No Audible Alarm
2827
2827
Break
325
325
Material Split, Cut or Torn
314
314
Leak/Splash
311
311
Insufficient Heating
305
305
Crack
276
276
Fluid/Blood Leak
202
202
Failure to Power Up
186
186
Device Alarm System
126
126
Detachment of Device or Device Component
113
113
Complete Loss of Power
82
82
Power Problem
57
57
Gas/Air Leak
54
54
Adverse Event Without Identified Device or Use Problem
53
53
Melted
51
51
Disconnection
51
51
Defective Alarm
44
44
Overfill
42
42
Temperature Problem
41
41
Mechanical Problem
41
41
Therapeutic or Diagnostic Output Failure
32
32
Overheating of Device
30
30
No Audible Prompt/Feedback
27
27
Material Puncture/Hole
27
27
Use of Device Problem
26
26
Defective Component
25
25
Infusion or Flow Problem
22
22
Obstruction of Flow
19
19
Improper Flow or Infusion
19
19
Defective Device
18
18
Device Displays Incorrect Message
18
18
Insufficient Information
17
17
Unexpected Shutdown
17
17
Output Problem
16
16
No Apparent Adverse Event
16
16
No Flow
15
15
Improper or Incorrect Procedure or Method
15
15
Misconnection
15
15
Protective Measures Problem
15
15
Incorrect, Inadequate or Imprecise Result or Readings
13
13
Loose or Intermittent Connection
13
13
Difficult to Open or Close
13
13
Failure to Deliver
12
12
Connection Problem
12
12
Moisture or Humidity Problem
12
12
Loss of Power
11
11
Device Sensing Problem
10
10
Fire
10
10
Material Integrity Problem
9
9
Device Handling Problem
9
9
Intermittent Loss of Power
9
9
Failure of Device to Self-Test
9
9
Unintended Movement
9
9
Device Emits Odor
8
8
Stretched
8
8
Noise, Audible
8
8
False Alarm
8
8
Display or Visual Feedback Problem
7
7
Filling Problem
7
7
Inaudible or Unclear Audible Prompt/Feedback
6
6
Failure to Sense
6
6
Sparking
6
6
Contamination /Decontamination Problem
6
6
Smoking
6
6
Degraded
5
5
Electrical /Electronic Property Problem
5
5
Failure to Read Input Signal
5
5
Material Deformation
5
5
Device Issue
5
5
Material Separation
4
4
Excessive Heating
4
4
Device Slipped
4
4
Device Damaged Prior to Use
4
4
Failure to Select Signal
4
4
Thermal Decomposition of Device
4
4
Corroded
4
4
Ambient Temperature Problem
4
4
Device Operates Differently Than Expected
3
3
Material Twisted/Bent
3
3
Human-Device Interface Problem
3
3
Loss of or Failure to Bond
3
3
Incorrect Measurement
3
3
Component Missing
3
3
Audible Prompt/Feedback Problem
3
3
No Device Output
3
3
Physical Resistance/Sticking
3
3
Complete Blockage
3
3
Hole In Material
2
2
Air Leak
2
2
Material Protrusion/Extrusion
2
2
Inaccurate Delivery
2
2
Cut In Material
2
2
Low Audible Alarm
2
2
Short Fill
2
2
Manufacturing, Packaging or Shipping Problem
2
2
No Display/Image
2
2
Unintended Ejection
2
2
Device Dislodged or Dislocated
2
2
Appropriate Term/Code Not Available
2
2
Failure to Reset
2
2
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
2522
2522
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
187
187
Insufficient Information
80
80
Death
25
25
No Information
14
14
Hypoxia
8
8
Bradycardia
8
8
Burn(s)
8
8
Respiratory Distress
7
7
Obstruction/Occlusion
6
6
Partial thickness (Second Degree) Burn
6
6
Cardiac Arrest
6
6
Dyspnea
4
4
Viral Infection
4
4
Airway Obstruction
4
4
Tachycardia
3
3
Patient Problem/Medical Problem
3
3
Pneumonia
3
3
Discomfort
3
3
Burn, Thermal
2
2
Pressure Sores
2
2
Increased Respiratory Rate
2
2
Full thickness (Third Degree) Burn
2
2
Aspiration/Inhalation
2
2
No Code Available
2
2
Respiratory Arrest
2
2
Arrhythmia
1
1
Stroke/CVA
1
1
Virus
1
1
Abrasion
1
1
Cyanosis
1
1
Inflammation
1
1
Swelling
1
1
Fibrosis
1
1
Complaint, Ill-Defined
1
1
Ventilator Dependent
1
1
Superficial (First Degree) Burn
1
1
Cough
1
1
Unspecified Respiratory Problem
1
1
Electric Shock
1
1
Myocardial Infarction
1
1
Chronic Obstructive Pulmonary Disease (COPD)
1
1
Bacterial Infection
1
1
Respiratory Insufficiency
1
1
Low Blood Pressure/ Hypotension
1
1
Neurological Deficit/Dysfunction
1
1
Skin Erosion
1
1
Respiratory Failure
1
1
Epistaxis
1
1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
1
1
Cancer
1
1
Erythema
1
1
Fever
1
1
Hypothermia
1
1
Blood Loss
1
1
Blister
1
1
Distress
1
1
Unspecified Infection
1
1
Pain
1
1
Asthma
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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