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TPLC
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show TPLC since
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2020
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2024
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Device
circulator, breathing-circuit
Product Code
CAG
Regulation Number
868.5250
Device Class
2
MDR Year
MDR Reports
MDR Events
2014
95
95
2015
41
41
2016
2
2
2017
2
2
2018
2
2
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
Leak/Splash
39
39
Melted
28
28
Break
18
18
Crack
15
15
Material Separation
13
13
Disconnection
11
11
Hole In Material
11
11
Split
11
11
Gas/Air Leak
11
11
Misassembled
9
9
Infusion or Flow Problem
7
7
Fitting Problem
5
5
Connection Problem
5
5
Device Inoperable
4
4
Material Puncture/Hole
4
4
Detachment Of Device Component
3
3
Loss of or Failure to Bond
3
3
Defective Component
3
3
Detachment of Device or Device Component
3
3
Failure to Deliver
3
3
Occlusion Within Device
3
3
Temperature Problem
2
2
Human-Device Interface Problem
2
2
Device Dislodged or Dislocated
2
2
Device Contamination with Chemical or Other Material
2
2
Thermal Decomposition of Device
2
2
Disassembly
2
2
Device Damaged Prior to Use
2
2
Mechanical Problem
2
2
Cut In Material
2
2
Failure to Align
1
1
Unintended Ejection
1
1
Material Fragmentation
1
1
Key or Button Unresponsive/not Working
1
1
Moisture or Humidity Problem
1
1
Alarm Not Visible
1
1
Material Rupture
1
1
No Fail-Safe Mechanism
1
1
Ambient Noise Problem
1
1
Material Integrity Problem
1
1
Device Operates Differently Than Expected
1
1
Torn Material
1
1
Suction Problem
1
1
Device Alarm System
1
1
Output Problem
1
1
Delivery System Failure
1
1
Device Displays Incorrect Message
1
1
Communication or Transmission Problem
1
1
Circuit Failure
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Consequences Or Impact To Patient
71
71
No Patient Involvement
63
63
No Clinical Signs, Symptoms or Conditions
38
38
No Known Impact Or Consequence To Patient
19
19
Insufficient Information
8
8
Low Oxygen Saturation
3
3
No Code Available
2
2
No Information
2
2
Death
1
1
Anxiety
1
1
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