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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device probe, thermodilution
Product CodeKRB
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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