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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device circulator, breathing-circuit
Regulation Description Breathing circuit circulator.
Product CodeCAG
Regulation Number 868.5250
Device Class 2

MDR Year MDR Reports MDR Events
2021 13 15
2022 9 9
2023 14 14
2024 3 3
2026 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Break 16 16
Material Separation 12 12
Gas/Air Leak 10 12
Material Puncture/Hole 4 4
Defective Component 3 3
Leak/Splash 2 2
Material Rupture 1 1
Fitting Problem 1 1
Device Damaged Prior to Use 1 1
Moisture or Humidity Problem 1 1
Output Problem 1 1
Key or Button Unresponsive/not Working 1 1
Alarm Not Visible 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 39 40
Insufficient Information 8 9

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