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TPLC - Total Product Life Cycle
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TPLC
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show TPLC since
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Device
conserver, oxygen
Regulation Description
Noncontinuous ventilator (IPPB).
Product Code
NFB
Regulation Number
868.5905
Device Class
2
Premarket Reviews
Manufacturer
Decision
DYNASTHETICS LLC
SUBSTANTIALLY EQUIVALENT
1
EFFORTLESS OXYGEN. LLC
SUBSTANTIALLY EQUIVALENT
1
INCOBA LTD. D/B/A DYNARIS
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2020
3
3
2021
2
2
2022
1
1
2023
4
4
2024
1
1
Device Problems
MDRs with this Device Problem
Events in those MDRs
Flare or Flash
2
2
Therapeutic or Diagnostic Output Failure
1
1
Inadequacy of Device Shape and/or Size
1
1
Thermal Decomposition of Device
1
1
Material Deformation
1
1
Component Missing
1
1
Scratched Material
1
1
Temperature Problem
1
1
Sharp Edges
1
1
No Flow
1
1
Improper Flow or Infusion
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
6
6
Superficial (First Degree) Burn
1
1
Pressure Sores
1
1
Insufficient Information
1
1
Ulcer
1
1
Burn(s)
1
1
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