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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device mask, oxygen, non-rebreathing
Product CodeKGB
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
Material Deformation 3 3
Detachment of Device or Device Component 3 3
Inflation Problem 2 2
Material Separation 2 2
Device Slipped 1 1
Inaccurate Delivery 1 1
Connection Problem 1 1
Decrease in Pressure 1 1
Break 1 1
Appropriate Term/Code Not Available 1 1
Patient Device Interaction Problem 1 1
Improper Flow or Infusion 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
Headache 2 2
Dizziness 2 2
Low Oxygen Saturation 1 1
Confusion/ Disorientation 1 1
No Patient Involvement 1 1
Insufficient Information 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Westmed, Inc. II Dec-29-2020
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