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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
Product CodeCAG
Regulation Number 868.5250
Device Class 2

MDR Year MDR Reports MDR Events
2019 3 3
2020 4 4
2021 13 13
2022 9 9
2023 14 14
2024 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Break 17 17
Material Separation 12 12
Gas/Air Leak 11 11
Leak/Splash 5 5
Material Puncture/Hole 4 4
Defective Component 3 3
Key or Button Unresponsive/not Working 1 1
Alarm Not Visible 1 1
Output Problem 1 1
Device Alarm System 1 1
Device Damaged Prior to Use 1 1
Fitting Problem 1 1
Material Fragmentation 1 1
Failure to Align 1 1
Moisture or Humidity Problem 1 1
Material Rupture 1 1
Detachment of Device or Device Component 1 1
Ambient Noise Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 38 38
Insufficient Information 8 8
No Consequences Or Impact To Patient 5 5
No Known Impact Or Consequence To Patient 1 1
No Patient Involvement 1 1

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