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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device humidifier, non-direct patient interface (home-use)
Product CodeKFZ
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 8 8

Device Problems MDRs with this Device Problem Events in those MDRs
Fire 253 253
Smoking 73 73
Melted 50 50
Use of Device Problem 49 49
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 24 24
Device Emits Odor 22 22
Break 17 17
Fluid/Blood Leak 17 17
Labelling, Instructions for Use or Training Problem 16 16
Device Handling Problem 16 16
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
Human-Device Interface Problem 8 8
Unexpected Therapeutic Results 8 8
Noise, Audible 6 6
Nonstandard Device 5 5
Leak/Splash 5 5
Component Falling 4 4
Device Inoperable 4 4
Structural Problem 3 3
Unintended Ejection 3 3
Malposition of Device 3 3
Defective Device 3 3
Temperature Problem 3 3
Hole In Material 3 3
Detachment Of Device Component 2 2
Mechanical Problem 2 2
Lack of Maintenance Documentation or Guidelines 2 2
Device Slipped 2 2
Failure to Shut Off 2 2
Therapeutic or Diagnostic Output Failure 2 2
No Apparent Adverse Event 2 2
Material Integrity Problem 2 2
Misconnection 1 1
Material Discolored 1 1
Flare or Flash 1 1
Material Disintegration 1 1
Precipitate in Device or Device Ingredient 1 1
Patient-Device Incompatibility 1 1
Device Dislodged or Dislocated 1 1
Gas Output Problem 1 1
Sediment, Precipitate Or Deposit In Device Or Device Ingredient 1 1
Particulates 1 1
Material Frayed 1 1
Residue After Decontamination 1 1
Explosion 1 1
Electrical /Electronic Property Problem 1 1
Incorrect, Inadequate or Imprecise Result or Readings 1 1
Improper Flow or Infusion 1 1
Crack 1 1
Detachment of Device or Device Component 1 1
Kinked 1 1
Device Markings/Labelling Problem 1 1
Device Unsafe to Use in Environment 1 1
Device Alarm System 1 1
Device Damaged Prior to Use 1 1
Fail-Safe Design Failure 1 1
Device Contamination with Chemical or Other Material 1 1
Device Damaged by Another Device 1 1
Fumes or Vapors 1 1
Off-Label Use 1 1
False Negative Result 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 72 72
Burn(s) 44 44
No Clinical Signs, Symptoms or Conditions 31 31
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
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