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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device centrifuges (micro, ultra, refrigerated) for clinical use
Regulation Description General purpose laboratory equipment labeled or promoted for a specific medical use.
Product CodeJQC
Regulation Number 862.2050
Device Class 1

MDR Year MDR Reports MDR Events
2021 1 1
2022 1 1
2023 4 10
2024 2 2
2025 6 6
2026 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Detachment of Device or Device Component 5 5
Unintended Electrical Shock 2 2
Sparking 1 1
Unexpected Shutdown 1 1
Incomplete or Inadequate Connection 1 7
Electrical Power Problem 1 1
Unintended Movement 1 1
Insufficient Information 1 1
Unsealed Device Packaging 1 1
Unintended Ejection 1 1
Use of Device Problem 1 1
Obstruction of Flow 1 1
Structural Problem 1 1
Infusion or Flow Problem 1 1
Difficult to Open or Close 1 7
Fluid/Blood Leak 1 1
No Device Output 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 13 19
Electric Shock 2 2
Exposure to Body Fluids 1 1
Insufficient Information 1 1
Tinnitus 1 1

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