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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device conserver, oxygen
Regulation Description Noncontinuous ventilator (IPPB).
Product CodeNFB
Regulation Number 868.5905
Device Class 2


Premarket Reviews
ManufacturerDecision
DYNASTHETICS, LLC
  SUBSTANTIALLY EQUIVALENT 1
EFFORTLESS OXYGEN, LLC
  SUBSTANTIALLY EQUIVALENT 1
RESPONSIVE RESPIRATORY
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2021 2 2
2022 1 1
2023 4 4
2024 1 1
2025 8 8
2026 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Loose or Intermittent Connection 4 4
Material Too Rigid or Stiff 2 2
Inadequacy of Device Shape and/or Size 2 2
Flare or Flash 2 2
Material Deformation 1 1
No Flow 1 1
Temperature Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
Incomplete or Inadequate Connection 1 1
Component Missing 1 1
Obstruction of Flow 1 1
Connection Problem 1 1
Detachment of Device or Device Component 1 1
Thermal Decomposition of Device 1 1
Disconnection 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 8 8
Low Oxygen Saturation 5 5
Pressure Sores 2 2
Superficial (First Degree) Burn 1 1
Burn(s) 1 1
Insufficient Information 1 1
Low Blood Pressure/ Hypotension 1 1

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