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TPLC - Total Product Life Cycle
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TPLC
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show TPLC since
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2024
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Device
probe, thermodilution
Product Code
KRB
Regulation Number
870.1915
Device Class
2
MDR Year
MDR Reports
MDR Events
2019
26
26
2020
16
16
2021
22
22
2022
21
21
2023
13
13
2024
9
9
Device Problems
MDRs with this Device Problem
Events in those MDRs
Break
33
33
Material Fragmentation
26
26
Leak/Splash
19
19
Incorrect Measurement
5
5
Adverse Event Without Identified Device or Use Problem
5
5
Difficult to Insert
4
4
Material Integrity Problem
3
3
Incorrect, Inadequate or Imprecise Result or Readings
2
2
Material Rupture
2
2
Crack
2
2
Fluid/Blood Leak
2
2
Fracture
2
2
Disconnection
1
1
Unable to Obtain Readings
1
1
Incomplete or Missing Packaging
1
1
Defective Device
1
1
Connection Problem
1
1
Manufacturing, Packaging or Shipping Problem
1
1
Material Twisted/Bent
1
1
Packaging Problem
1
1
Insufficient Information
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
50
50
No Consequences Or Impact To Patient
34
34
Foreign Body In Patient
6
6
No Known Impact Or Consequence To Patient
5
5
Insufficient Information
4
4
Device Embedded In Tissue or Plaque
3
3
Ischemia
3
3
Infarction, Cerebral
2
2
Vascular Dissection
2
2
No Patient Involvement
1
1
Hemorrhage/Bleeding
1
1
Air Embolism
1
1
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