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 Code	KFZ
Regulation Number	868.5460
Device Class	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Use of Device Problem	38	38
Patient Device Interaction Problem	31	31
Labelling, Instructions for Use or Training Problem	25	25
Device Handling Problem	19	19
Human-Device Interface Problem	14	14
Unexpected Therapeutic Results	9	9
Excessive Heating	3	3
Adverse Event Without Identified Device or Use Problem	3	3
Malposition of Device	2	2
Device Tipped Over	2	2
Insufficient Device Problem Information	2	2
Lack of Maintenance Documentation or Guidelines	2	2
Burst Container or Vessel	1	1
Off-Label Use	1	1
No Apparent Adverse Event	1	1
Inadequate User Interface	1	1
Misconnection	1	1
Device Damaged by Another Device	1	1
Misassembly by Users	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	36	36
Partial thickness (Second Degree) Burn	27	27
Insufficient Information	20	21
Burn(s)	14	14
Full thickness (Third Degree) Burn	10	10
Superficial (First Degree) Burn	5	5
Cough	4	4
Blister	3	3
Aspiration/Inhalation	3	3
Erythema	2	2
Sore Throat	1	1
Bronchitis	1	1
Skin Discoloration	1	1
Chest Pain	1	1
Scar Tissue	1	1
Hypersensitivity/Allergic reaction	1	1
Pain	1	1
Viral Infection	1	1
Discomfort	1	1
Vomiting	1	1

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