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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
2020 4 4
2021 1 1
2022 1 1
2023 4 4
2024 2 2
2025 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Break 3 3
Detachment of Device or Device Component 3 3
Unintended Electrical Shock 2 2
Sparking 1 1
Unexpected Shutdown 1 1
Incomplete or Inadequate Connection 1 1
Electrical Power Problem 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
Infusion or Flow Problem 1 1
Difficult to Open or Close 1 1
No Device Output 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 9 9
Electric Shock 2 2
No Known Impact Or Consequence To Patient 2 2
Injury 1 1
Insufficient Information 1 1
Tinnitus 1 1

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