Quick Links: Skip to main page content
Skip to Search
Skip to Topics Menu
Skip to Common Links
U.S. Food & Drug Administration
Follow FDA
En Español
Search FDA
Home
Food
Drugs
Medical Devices
Radiation-Emitting Products
Vaccines, Blood & Biologics
Animal & Veterinary
Cosmetics
Tobacco Products
TPLC - Total Product Life Cycle
FDA Home
medical devices
databases
-
510(k)
|
DeNovo
|
Registration & Listing
|
Adverse Events
|
Recalls
|
PMA
|
HDE
|
Classification
|
Standards
CFR Title 21
|
Radiation-Emitting Products
|
X-Ray Assembler
|
Medsun Reports
|
CLIA
|
TPLC
New Search
show TPLC since
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
Back to Search Results
Device
humidifier, non-direct patient interface (home-use)
Product Code
KFZ
Regulation Number
868.5460
Device Class
1
MDR Year
MDR Reports
MDR Events
2014
90
90
2015
77
77
2016
84
84
2017
93
93
2018
59
59
2019
41
41
2020
32
32
2021
32
32
2022
24
24
2023
22
22
2024
6
6
Device Problems
MDRs with this Device Problem
Events in those MDRs
Fire
253
253
Smoking
73
73
Melted
50
50
Use of Device Problem
48
48
Adverse Event Without Identified Device or Use Problem
37
37
Improper or Incorrect Procedure or Method
28
28
Thermal Decomposition of Device
27
27
Patient Device Interaction Problem
23
23
Device Emits Odor
22
22
Break
17
17
Fluid/Blood Leak
17
17
Device Handling Problem
16
16
Labelling, Instructions for Use or Training Problem
15
15
Overheating of Device
14
14
Sparking
14
14
Burst Container or Vessel
13
13
Device Operates Differently Than Expected
12
12
Device Tipped Over
10
10
Insufficient Information
10
10
Unexpected Therapeutic Results
8
8
Human-Device Interface Problem
7
7
Noise, Audible
6
6
Nonstandard Device
5
5
Leak/Splash
5
5
Device Inoperable
4
4
Component Falling
4
4
Unintended Ejection
3
3
Hole In Material
3
3
Temperature Problem
3
3
Defective Device
3
3
Structural Problem
3
3
Malposition of Device
3
3
Failure to Shut Off
2
2
Therapeutic or Diagnostic Output Failure
2
2
No Apparent Adverse Event
2
2
Lack of Maintenance Documentation or Guidelines
2
2
Material Integrity Problem
2
2
Detachment Of Device Component
2
2
Device Slipped
2
2
Mechanical Problem
2
2
Misconnection
1
1
Particulates
1
1
Precipitate in Device or Device Ingredient
1
1
Off-Label Use
1
1
Incorrect, Inadequate or Imprecise Result or Readings
1
1
Device Damaged Prior to Use
1
1
Residue After Decontamination
1
1
Device Alarm System
1
1
Crack
1
1
Material Discolored
1
1
Material Disintegration
1
1
Electrical /Electronic Property Problem
1
1
Fail-Safe Design Failure
1
1
False Negative Result
1
1
Kinked
1
1
Material Frayed
1
1
Gas Output Problem
1
1
Sediment, Precipitate Or Deposit In Device Or Device Ingredient
1
1
Explosion
1
1
Flare or Flash
1
1
Device Contamination with Chemical or Other Material
1
1
Improper Flow or Infusion
1
1
Device Damaged by Another Device
1
1
Device Unsafe to Use in Environment
1
1
Device Dislodged or Dislocated
1
1
Patient-Device Incompatibility
1
1
Detachment of Device or Device Component
1
1
Device Markings/Labelling Problem
1
1
Fumes or Vapors
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Known Impact Or Consequence To Patient
174
174
No Consequences Or Impact To Patient
161
161
Partial thickness (Second Degree) Burn
71
71
Burn(s)
44
44
No Clinical Signs, Symptoms or Conditions
30
30
Insufficient Information
23
23
Superficial (First Degree) Burn
17
17
Burn, Thermal
16
16
Full thickness (Third Degree) Burn
16
16
No Information
9
9
Complaint, Ill-Defined
4
4
Injury
4
4
Swelling
3
3
Respiratory Distress
2
2
Electric Shock
2
2
No Code Available
2
2
Cough
2
2
Blister
1
1
Not Applicable
1
1
Chemical Exposure
1
1
Foreign Body In Patient
1
1
Patient Problem/Medical Problem
1
1
Sore Throat
1
1
Low Oxygen Saturation
1
1
Eye Burn
1
1
Scar Tissue
1
1
Skin Discoloration
1
1
Syncope
1
1
Aspiration/Inhalation
1
1
Loss of Vision
1
1
Vomiting
1
1
Viral Infection
1
1
Anxiety
1
1
Chest Pain
1
1
Death
1
1
Erythema
1
1
Fall
1
1
Fever
1
1
Bone Fracture(s)
1
1
Hypersensitivity/Allergic reaction
1
1
Laceration(s)
1
1
Pain
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Bigwall Enterprises
II
Feb-25-2016
2
Cardinal Health Inc.
II
Jun-23-2021
-
-