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TPLC
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show TPLC since
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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
Gas/Air Leak
11
11
Split
11
11
Hole In Material
11
11
Misassembled
9
9
Infusion or Flow Problem
7
7
Fitting Problem
5
5
Connection Problem
5
5
Material Puncture/Hole
4
4
Device Inoperable
4
4
Failure to Deliver
3
3
Occlusion Within Device
3
3
Detachment of Device or Device Component
3
3
Defective Component
3
3
Detachment Of Device Component
3
3
Loss of or Failure to Bond
3
3
Cut In Material
2
2
Human-Device Interface Problem
2
2
Device Contamination with Chemical or Other Material
2
2
Mechanical Problem
2
2
Thermal Decomposition of Device
2
2
Device Damaged Prior to Use
2
2
Temperature Problem
2
2
Disassembly
2
2
Device Dislodged or Dislocated
2
2
Suction Problem
1
1
Material Rupture
1
1
Moisture or Humidity Problem
1
1
Material Fragmentation
1
1
Device Displays Incorrect Message
1
1
Device Operates Differently Than Expected
1
1
No Fail-Safe Mechanism
1
1
Material Integrity Problem
1
1
Torn Material
1
1
Device Alarm System
1
1
Output Problem
1
1
Communication or Transmission Problem
1
1
Delivery System Failure
1
1
Ambient Noise Problem
1
1
Unintended Ejection
1
1
Failure to Align
1
1
Alarm Not Visible
1
1
Key or Button Unresponsive/not Working
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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