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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device absorbent, carbon-dioxide
Regulation Description Carbon dioxide absorbent.
Product CodeCBL
Regulation Number 868.5300
Device Class 1

MDR Year MDR Reports MDR Events
2021 22 22
2022 20 20
2023 9 9
2024 6 6
2025 17 17
2026 5 5

Device Problems MDRs with this Device Problem Events in those MDRs
Leak/Splash 35 35
Crack 8 8
Gas/Air Leak 8 8
Material Integrity Problem 6 6
Mechanical Problem 4 4
Product Quality Problem 3 3
Break 2 2
Output Problem 2 2
Device Damaged Prior to Use 2 2
Defective Component 2 2
Defective Device 2 2
Therapeutic or Diagnostic Output Failure 2 2
No Pressure 2 2
Reset Problem 1 1
Volume Accuracy Problem 1 1
Physical Resistance/Sticking 1 1
Failure to Recalibrate 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Contamination 1 1
Incorrect, Inadequate or Imprecise Result or Readings 1 1
Battery Problem 1 1
Material Discolored 1 1
Obstruction of Flow 1 1
Decrease in Pressure 1 1
Fracture 1 1
Failure of Device to Self-Test 1 1
Gas Output Problem 1 1
No Flow 1 1
Intermittent Communication Failure 1 1
Loss of or Failure to Bond 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 61 61
Insufficient Information 11 11
Low Oxygen Saturation 6 6
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Armstrong Medical Services Limited I Sep-13-2021
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