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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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New Search show TPLC since Back to Search Results
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 18 18

Device Problems MDRs with this Device Problem Events in those MDRs
Break 36 36
Material Fragmentation 27 27
Leak/Splash 21 21
Incorrect Measurement 8 8
Adverse Event Without Identified Device or Use Problem 5 5
Material Integrity Problem 4 4
Difficult to Insert 4 4
Fluid/Blood Leak 3 3
Fracture 2 2
Crack 2 2
Incorrect, Inadequate or Imprecise Result or Readings 2 2
Material Rupture 2 2
Incomplete or Missing Packaging 1 1
Defective Device 1 1
Connection Problem 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Packaging Problem 1 1
Insufficient Information 1 1
Appropriate Term/Code Not Available 1 1
Disconnection 1 1
Unable to Obtain Readings 1 1
Material Frayed 1 1
Material Twisted/Bent 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 59 59
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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