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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device probe, thermodilution
Regulation Description Thermodilution probe.
Product CodeKRB
Regulation Number 870.1915
Device Class 2

MDR Year MDR Reports MDR Events
2021 22 26
2022 21 21
2023 13 13
2024 33 40
2025 6 24
2026 2 5

Device Problems MDRs with this Device Problem Events in those MDRs
Break 33 37
Material Fragmentation 18 18
Fluid/Blood Leak 14 21
Incorrect Measurement 9 9
Stretched 8 17
Leak/Splash 7 7
Detachment of Device or Device Component 5 5
Crack 4 6
Material Integrity Problem 4 4
Fracture 3 3
Incorrect, Inadequate or Imprecise Result or Readings 2 2
Material Twisted/Bent 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Appropriate Term/Code Not Available 2 2
Disconnection 1 1
Material Frayed 1 1
Mechanical Problem 1 1
Incomplete or Missing Packaging 1 1
Insufficient Information 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Contamination 1 1
Unraveled Material 1 2
Material Deformation 1 3

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 76 105
Foreign Body In Patient 11 12
Insufficient Information 4 4
Hemorrhage/Bleeding 3 3
No Consequences Or Impact To Patient 3 3
Ischemia 2 2
Shock 2 2
Vascular Dissection 2 2
No Known Impact Or Consequence To Patient 1 1
No Patient Involvement 1 1

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