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TPLC
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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
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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