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TPLC
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show TPLC since
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Device
unit, liquid-oxygen, portable
Product Code
BYJ
Regulation Number
868.5655
Device Class
2
MDR Year
MDR Reports
MDR Events
2019
24
24
2020
39
39
2021
7
7
2022
4
4
2023
10
10
Device Problems
MDRs with this Device Problem
Events in those MDRs
Fluid/Blood Leak
45
45
Use of Device Problem
8
8
Fire
8
8
Leak/Splash
7
7
Defective Component
6
6
Insufficient Information
4
4
Adverse Event Without Identified Device or Use Problem
3
3
Detachment of Device or Device Component
2
2
Infusion or Flow Problem
2
2
Material Integrity Problem
1
1
Gas/Air Leak
1
1
No Pressure
1
1
Defective Device
1
1
Activation, Positioning or Separation Problem
1
1
Improper or Incorrect Procedure or Method
1
1
Mechanical Problem
1
1
Burst Container or Vessel
1
1
Crack
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Consequences Or Impact To Patient
21
21
Burn(s)
17
17
Burn, Thermal
16
16
Cryogenic Burn
12
12
Insufficient Information
5
5
No Clinical Signs, Symptoms or Conditions
4
4
No Known Impact Or Consequence To Patient
4
4
Death
3
3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
2
2
Partial thickness (Second Degree) Burn
1
1
Full thickness (Third Degree) Burn
1
1
No Code Available
1
1
Hemorrhage/Bleeding
1
1
Hyperglycemia
1
1
Hypoxia
1
1
Chronic Obstructive Pulmonary Disease (COPD)
1
1
Low Oxygen Saturation
1
1
Pulmonary Embolism
1
1
Abrasion
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Caire, Inc.
I
Dec-02-2022
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