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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
2016 4 4
2018 4 4
2019 4 4
2020 10 10

Device Problems MDRs with this Device Problem Events in those MDRs
Crack 7 7
Leak/Splash 4 4
Device Operates Differently Than Expected 3 3
Gas Leak 2 2
Mechanical Jam 1 1
Filtration Problem 1 1
Filter 1 1
Break 1 1
Gas Output Problem 1 1
Inadequate Instructions for Healthcare Professional 1 1
Mechanical Problem 1 1
Component or Accessory Incompatibility 1 1
Decrease in Pressure 1 1
Moisture or Humidity Problem 1 1
Data Problem 1 1
Housing 1 1
Device Alarm System 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 7 7
No Known Impact Or Consequence To Patient 5 5
No Patient Involvement 3 3
No Clinical Signs, Symptoms or Conditions 2 2
Low Oxygen Saturation 1 1
Hyperthermia 1 1
No Information 1 1
Muscular Rigidity 1 1
Respiratory Distress 1 1
Hypoesthesia, Arm/Hand 1 1

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