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TPLC - Total Product Life Cycle
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TPLC
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Device
mask, oxygen, non-rebreathing
Product Code
KGB
Regulation Number
868.5570
Device Class
1
MDR Year
MDR Reports
MDR Events
2019
1
1
2020
9
9
2022
6
6
2023
2
2
Device Problems
MDRs with this Device Problem
Events in those MDRs
Gas/Air Leak
5
5
Detachment of Device or Device Component
3
3
Material Deformation
3
3
Material Separation
2
2
Inflation Problem
2
2
Device Slipped
1
1
Break
1
1
Improper Flow or Infusion
1
1
Connection Problem
1
1
Decrease in Pressure
1
1
Inaccurate Delivery
1
1
Appropriate Term/Code Not Available
1
1
Patient Device Interaction Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Consequences Or Impact To Patient
8
8
No Clinical Signs, Symptoms or Conditions
4
4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
2
2
Dizziness
2
2
Headache
2
2
Confusion/ Disorientation
1
1
No Patient Involvement
1
1
Insufficient Information
1
1
Low Oxygen Saturation
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Westmed, Inc.
II
Dec-29-2020
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