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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)
Regulation Description Therapeutic humidifier for home use.
Product CodeKFZ
Regulation Number 868.5460
Device Class 1

MDR Year MDR Reports MDR Events
2020 32 32
2021 32 32
2022 24 24
2023 22 22
2024 13 13
2025 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Use of Device Problem 39 39
Fire 37 37
Patient Device Interaction Problem 27 27
Labelling, Instructions for Use or Training Problem 19 19
Device Handling Problem 15 15
Unexpected Therapeutic Results 9 9
Smoking 8 8
Human-Device Interface Problem 8 8
Adverse Event Without Identified Device or Use Problem 4 4
Device Tipped Over 3 3
Malposition of Device 3 3
Leak/Splash 2 2
Insufficient Information 2 2
Defective Device 2 2
Structural Problem 2 2
Fluid/Blood Leak 2 2
Lack of Maintenance Documentation or Guidelines 2 2
Burst Container or Vessel 1 1
Device Markings/Labelling Problem 1 1
Misconnection 1 1
Temperature Problem 1 1
Device Damaged by Another Device 1 1
Incorrect, Inadequate or Imprecise Result or Readings 1 1
Flare or Flash 1 1
Failure to Shut Off 1 1
Fumes or Vapors 1 1
No Apparent Adverse Event 1 1
Off-Label Use 1 1
Overheating of Device 1 1
Patient-Device Incompatibility 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 33 33
Partial thickness (Second Degree) Burn 30 30
Insufficient Information 23 23
Burn(s) 12 12
Full thickness (Third Degree) Burn 11 11
No Known Impact Or Consequence To Patient 11 11
Superficial (First Degree) Burn 4 4
Aspiration/Inhalation 2 2
Blister 2 2
No Consequences Or Impact To Patient 2 2
Cough 2 2
Erythema 2 2
Electric Shock 1 1
Sore Throat 1 1
Hypersensitivity/Allergic reaction 1 1
Injury 1 1
Viral Infection 1 1
Chest Pain 1 1
Pain 1 1
Scar Tissue 1 1
Vomiting 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Cardinal Health Inc. II Jun-23-2021
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