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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device flowmeter, tube, thorpe, back-pressure compensated
Regulation Description Compensated thorpe tube flowmeter.
Product CodeCAX
Regulation Number 868.2340
Device Class 1

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

Device Problems MDRs with this Device Problem Events in those MDRs
Burst Container or Vessel 2 2
Therapeutic or Diagnostic Output Failure 2 2
Use of Device Problem 2 2
Misassembly by Users 2 2
Gas Output Problem 2 2
Break 1 1
Unsealed Device Packaging 1 1
Defective Component 1 1
Improper Flow or Infusion 1 1
Misassembled 1 1
Material Rupture 1 1
Free or Unrestricted Flow 1 1
Improper or Incorrect Procedure or Method 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 7 7
Low Oxygen Saturation 5 5
Death 2 2
Insufficient Information 1 1
Bradycardia 1 1
Hypoxia 1 1

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