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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device analyzer, heparin, automated
Regulation Description Automated heparin analyzer.
Product CodeJOX
Regulation Number 864.5680
Device Class 2

MDR Year MDR Reports MDR Events
2022 29 29
2023 50 50
2024 30 30
2025 69 69
2026 12 12

Device Problems MDRs with this Device Problem Events in those MDRs
Electrical /Electronic Property Problem 166 166
Incorrect, Inadequate or Imprecise Result or Readings 11 11
Mechanical Problem 10 10
Delivered as Unsterile Product 9 9
Device Alarm System 7 7
Power Problem 1 1
Noise, Audible 1 1
Use of Incorrect Control/Treatment Settings 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 190 190

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