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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 8 8

Device Problems MDRs with this Device Problem Events in those MDRs
Fire 58 58
Use of Device Problem 46 46
Patient Device Interaction Problem 24 24
Smoking 16 16
Labelling, Instructions for Use or Training Problem 16 16
Device Handling Problem 14 14
Unexpected Therapeutic Results 8 8
Adverse Event Without Identified Device or Use Problem 7 7
Human-Device Interface Problem 5 5
Device Tipped Over 3 3
Malposition of Device 3 3
Insufficient Information 3 3
Leak/Splash 3 3
Overheating of Device 3 3
Fluid/Blood Leak 2 2
Structural Problem 2 2
Defective Device 2 2
No Apparent Adverse Event 2 2
Temperature Problem 2 2
Lack of Maintenance Documentation or Guidelines 2 2
Sparking 1 1
Patient-Device Incompatibility 1 1
Device Markings/Labelling Problem 1 1
Device Damaged by Another Device 1 1
Failure to Shut Off 1 1
Flare or Flash 1 1
Therapeutic or Diagnostic Output Failure 1 1
Burst Container or Vessel 1 1
Fumes or Vapors 1 1
Improper or Incorrect Procedure or Method 1 1
Off-Label Use 1 1
Incorrect, Inadequate or Imprecise Result or Readings 1 1
Misconnection 1 1
Device Emits Odor 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Partial thickness (Second Degree) Burn 38 38
No Clinical Signs, Symptoms or Conditions 31 31
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 9 9
Superficial (First Degree) Burn 6 6
Burn, Thermal 2 2
Cough 2 2
Blister 1 1
Electric Shock 1 1
Patient Problem/Medical Problem 1 1
Viral Infection 1 1
Complaint, Ill-Defined 1 1
Injury 1 1
Sore Throat 1 1
Chest Pain 1 1
Hypersensitivity/Allergic reaction 1 1
Pain 1 1
Scar Tissue 1 1
Vomiting 1 1
Aspiration/Inhalation 1 1

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