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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
2020 16 16
2021 22 26
2022 21 21
2023 13 13
2024 33 40
2025 6 24
2026 5 13

Device Problems MDRs with this Device Problem Events in those MDRs
Break 35 39
Material Fragmentation 20 20
Fluid/Blood Leak 15 23
Leak/Splash 13 13
Incorrect Measurement 10 10
Stretched 9 19
Detachment of Device or Device Component 5 5
Crack 4 8
Material Integrity Problem 4 4
Adverse Event Without Identified Device or Use Problem 4 4
Fracture 4 4
Incorrect, Inadequate or Imprecise Result or Readings 3 3
Difficult to Insert 2 2
Material Twisted/Bent 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
Defective Device 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Contamination 1 1
Unable to Obtain Readings 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 79 113
No Consequences Or Impact To Patient 14 14
Foreign Body In Patient 11 12
Insufficient Information 5 5
Hemorrhage/Bleeding 3 3
Infarction, Cerebral 2 2
Vascular Dissection 2 2
Ischemia 2 2
Shock 2 2
Air Embolism 1 1
No Known Impact Or Consequence To Patient 1 1
No Patient Involvement 1 1
Device Embedded In Tissue or Plaque 1 1

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