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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
Product CodeCBL
Regulation Number 868.5300
Device Class 1

MDR Year MDR Reports MDR Events
2015 2 2
2016 4 4
2018 4 4
2019 4 4
2020 10 10
2021 22 22
2022 20 20
2023 9 9
2024 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Leak/Splash 31 31
Crack 13 13
Mechanical Problem 5 5
Device Operates Differently Than Expected 4 4
Gas/Air Leak 3 3
Break 3 3
Gas Output Problem 2 2
Decrease in Pressure 2 2
Device Damaged Prior to Use 2 2
Output Problem 2 2
Therapeutic or Diagnostic Output Failure 2 2
Material Integrity Problem 2 2
Mechanical Jam 1 1
Moisture or Humidity Problem 1 1
No Pressure 1 1
Filtration Problem 1 1
Loose or Intermittent Connection 1 1
Data Problem 1 1
Physical Resistance/Sticking 1 1
Intermittent Communication Failure 1 1
Reset Problem 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Defective Component 1 1
Defective Device 1 1
Battery Problem 1 1
Component or Accessory Incompatibility 1 1
Product Quality Problem 1 1
Failure to Recalibrate 1 1
Incorrect, Inadequate or Imprecise Result or Readings 1 1
Volume Accuracy Problem 1 1
Inadequate Instructions for Healthcare Professional 1 1
Material Discolored 1 1
Fracture 1 1
Contamination 1 1
Device Alarm System 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 47 47
Insufficient Information 7 7
No Consequences Or Impact To Patient 7 7
No Known Impact Or Consequence To Patient 6 6
No Patient Involvement 3 3
Low Oxygen Saturation 2 2
No Information 1 1
Toxicity 1 1
Hypoesthesia, Arm/Hand 1 1
Hyperthermia 1 1
Muscular Rigidity 1 1
Respiratory Distress 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Allied Healthcare Products Inc II May-06-2011
2 Armstrong Medical Services Limited I Sep-13-2021
3 Darex Container Products Div of W.R. Grace & Co. II Dec-08-2010
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