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TPLC
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show TPLC since
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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
13
13
Device Problems
MDRs with this Device Problem
Events in those MDRs
Fire
253
253
Smoking
73
73
Use of Device Problem
51
51
Melted
50
50
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
26
26
Device Emits Odor
22
22
Labelling, Instructions for Use or Training Problem
17
17
Device Handling Problem
17
17
Break
17
17
Fluid/Blood Leak
17
17
Sparking
14
14
Overheating of Device
14
14
Burst Container or Vessel
13
13
Device Operates Differently Than Expected
12
12
Insufficient Information
11
11
Human-Device Interface Problem
10
10
Device Tipped Over
10
10
Unexpected Therapeutic Results
9
9
Noise, Audible
6
6
Nonstandard Device
5
5
Leak/Splash
5
5
Component Falling
4
4
Device Inoperable
4
4
Temperature Problem
3
3
Hole In Material
3
3
Malposition of Device
3
3
Unintended Ejection
3
3
Structural Problem
3
3
Defective Device
3
3
Device Slipped
2
2
Detachment Of Device Component
2
2
Failure to Shut Off
2
2
Mechanical Problem
2
2
No Apparent Adverse Event
2
2
Lack of Maintenance Documentation or Guidelines
2
2
Material Integrity Problem
2
2
Therapeutic or Diagnostic Output Failure
2
2
Fumes or Vapors
1
1
Explosion
1
1
Device Contamination with Chemical or Other Material
1
1
Detachment of Device or Device Component
1
1
Material Frayed
1
1
Device Alarm System
1
1
Residue After Decontamination
1
1
Device Damaged by Another Device
1
1
Particulates
1
1
Device Damaged Prior to Use
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
73
73
Burn(s)
44
44
No Clinical Signs, Symptoms or Conditions
32
32
Insufficient Information
23
23
Full thickness (Third Degree) Burn
18
18
Superficial (First Degree) Burn
18
18
Burn, Thermal
16
16
No Information
9
9
Injury
4
4
Complaint, Ill-Defined
4
4
Erythema
3
3
Swelling
3
3
No Code Available
2
2
Respiratory Distress
2
2
Blister
2
2
Electric Shock
2
2
Cough
2
2
Not Applicable
1
1
Hypersensitivity/Allergic reaction
1
1
Bone Fracture(s)
1
1
Aspiration/Inhalation
1
1
Eye Burn
1
1
Chemical Exposure
1
1
Skin Discoloration
1
1
Syncope
1
1
Fever
1
1
Foreign Body In Patient
1
1
Death
1
1
Viral Infection
1
1
Chest Pain
1
1
Vomiting
1
1
Fall
1
1
Laceration(s)
1
1
Pain
1
1
Scar Tissue
1
1
Anxiety
1
1
Patient Problem/Medical Problem
1
1
Loss of Vision
1
1
Sore Throat
1
1
Low Oxygen Saturation
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Bigwall Enterprises
II
Feb-25-2016
2
Cardinal Health Inc.
II
Jun-23-2021
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