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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
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 58 58
Use of Device Problem 48 48
Patient Device Interaction Problem 26 26
Labelling, Instructions for Use or Training Problem 17 17
Smoking 16 16
Device Handling Problem 15 15
Unexpected Therapeutic Results 9 9
Adverse Event Without Identified Device or Use Problem 7 7
Human-Device Interface Problem 7 7
Insufficient Information 4 4
Leak/Splash 3 3
Device Tipped Over 3 3
Malposition of Device 3 3
Overheating of Device 3 3
Structural Problem 2 2
No Apparent Adverse Event 2 2
Temperature Problem 2 2
Fluid/Blood Leak 2 2
Defective Device 2 2
Lack of Maintenance Documentation or Guidelines 2 2
Sparking 1 1
Fumes or Vapors 1 1
Failure to Shut Off 1 1
Off-Label Use 1 1
Burst Container or Vessel 1 1
Device Markings/Labelling Problem 1 1
Patient-Device Incompatibility 1 1
Incorrect, Inadequate or Imprecise Result or Readings 1 1
Flare or Flash 1 1
Device Damaged by Another Device 1 1
Misconnection 1 1
Device Emits Odor 1 1
Therapeutic or Diagnostic Output Failure 1 1
Improper or Incorrect Procedure or Method 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Partial thickness (Second Degree) Burn 39 39
No Clinical Signs, Symptoms or Conditions 32 32
No Known Impact Or Consequence To Patient 28 28
Insufficient Information 23 23
Burn(s) 13 13
No Consequences Or Impact To Patient 11 11
Full thickness (Third Degree) Burn 11 11
Superficial (First Degree) Burn 7 7
Burn, Thermal 2 2
Blister 2 2
Erythema 2 2
Cough 2 2
Patient Problem/Medical Problem 1 1
Complaint, Ill-Defined 1 1
Electric Shock 1 1
Hypersensitivity/Allergic reaction 1 1
Aspiration/Inhalation 1 1
Injury 1 1
Viral Infection 1 1
Chest Pain 1 1
Vomiting 1 1
Pain 1 1
Scar Tissue 1 1
Sore Throat 1 1

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