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TPLC - Total Product Life Cycle
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TPLC
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show TPLC since
2009
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2011
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2019
2020
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2024
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Device
absorbent, carbon-dioxide
Product Code
CBL
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
5
5
Device Problems
MDRs with this Device Problem
Events in those MDRs
Leak/Splash
32
32
Crack
13
13
Mechanical Problem
5
5
Gas/Air Leak
5
5
Device Operates Differently Than Expected
4
4
Break
3
3
Defective Device
2
2
Material Integrity Problem
2
2
Therapeutic or Diagnostic Output Failure
2
2
Defective Component
2
2
Output Problem
2
2
Device Damaged Prior to Use
2
2
Gas Output Problem
2
2
Decrease in Pressure
2
2
Reset Problem
1
1
Component or Accessory Incompatibility
1
1
Failure to Recalibrate
1
1
Manufacturing, Packaging or Shipping Problem
1
1
Physical Resistance/Sticking
1
1
Volume Accuracy Problem
1
1
Device Alarm System
1
1
Filtration Problem
1
1
Incorrect, Inadequate or Imprecise Result or Readings
1
1
Inadequate Instructions for Healthcare Professional
1
1
Contamination
1
1
Fracture
1
1
Mechanical Jam
1
1
Loose or Intermittent Connection
1
1
Intermittent Communication Failure
1
1
Loss of or Failure to Bond
1
1
Battery Problem
1
1
No Pressure
1
1
Material Discolored
1
1
Moisture or Humidity Problem
1
1
Data Problem
1
1
Product Quality Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
47
47
Insufficient Information
10
10
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
Respiratory Distress
1
1
No Information
1
1
Hypoesthesia, Arm/Hand
1
1
Muscular Rigidity
1
1
Hyperthermia
1
1
Toxicity
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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