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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
2017 3 3
2018 5 5
2019 1 1
2020 9 9
2022 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Inflation Problem 5 5
Gas Leak 4 4
Detachment of Device or Device Component 2 2
No Flow 1 1
Break 1 1
Device Slipped 1 1
Disconnection 1 1
Device Displays Incorrect Message 1 1
Burst Container or Vessel 1 1
Material Separation 1 1
Leak/Splash 1 1
Fitting Problem 1 1
Defective Component 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 12 12
Headache 2 2
Dizziness 2 2
Low Oxygen Saturation 2 2
Death 1 1
Shock 1 1
No Code Available 1 1
No Patient Involvement 1 1
No Known Impact Or Consequence To Patient 1 1
No Clinical Signs, Symptoms or Conditions 1 1

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